A government study about the costs of providing oxygen therapy in the home is deeply flawed according to the American Association for Homecare. Moreover, the further erosion of the oxygen benefit recommended by the report and by CMS will put oxygen patients at even greater risk than they are already, says the Association.
On September 14, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a study about the cost of home oxygen under Medicare. The American Association for Homecare cited a 2006 study it commissioned from Morrison Informatics as a more accurate analysis of the costs of oxygen therapy provided in the home.
The American Association for Homecare expressed appreciation for the visits the OIG made to oxygen providers, patients, and referral sources. However, the OIG study does not reflect the full range of services provided to patients nor does it reflect the actual costs incurred in providing them. Moreover, the OIG looks at old cost data, from 2003. The Morrison Informatics study reviewed all current oxygen-related services for 2006.
The Association cited several areas of concern regarding the OIG study:
-- The study focuses primarily on the cost of acquiring oxygen concentrators, which is a small fraction of the complete cost of providing oxygen therapy to Medicare patients in the home. (The Morrison study shows that equipment costs represent only 28 percent of the total cost of providing oxygen therapy.) The OIG study does not consider the full range of services and costs required in providing oxygen therapy.
-- OIG notes that other costs were not considered because they are included in the fee schedule amounts that are based on historical reimbursement levels of nearly 20 years ago. During recent decades, transportation, regulatory compliance, insurance, and other costs have increased while oxygen reimbursement under Medicare has declined sharply.
-- The OIG study only asked for cost information about oxygen concentrators. The study should have looked at all types of oxygen modalities including liquid and the full costs of portable oxygen systems.It did not collect data about the acquisition cost for all of the portable tanks, regulators, oxygen conserving devices, cannulas, tubing, and other tangible equipment and supplies provided to home oxygen patients.
-- The report does not consider average delivery cost per patient, average miles driven, average customer service time, bad debt, or Medicare-required documentation and compliance costs. An accurate accounting of costs should acknowledge that healthcare reimbursements should factor in rent, utilities, insurance and other costs, which are considered in other healthcare sectors.
-- The OIG study gathered information only about new users of oxygen who began services in 2004 and who had no services previous to that year. Because COPD is a progressive disease, new users often start with nocturnal use only, and longer-term patients require more service.
-- The OIG presented data that suggests that all patients rent oxygen for 36 months. Their own data shows that 78 percent never reach the 36th month.
-- The 145 patients in the sample represent about one one-hundredth of one percent of total beneficiaries using oxygen therapy at home.
The Morrison Study Commissioned by the American Association for Homecare
Earlier this year, the American Association for Homecare commissioned a study by Morrison Informatics to study the costs of providing oxygen therapy in the home. Morrison collected and analyzed data from homecare providers that collectively serve more than 600,000 Medicare beneficiaries receiving oxygen therapy in their homes, which represents more than half of the Medicare population receiving oxygen therapy at home.
The study found that nearly three-quarters (72 percent) of the cost of providing home oxygen therapy to Medicare patients in their homes represent services, delivery, and other operational expenses that benefit patients. Only about one-quarter (28 percent) of the cost represents oxygen equipment.
?"It is time that CMS and Congress recognize that the services captured in this Morrison study represent the industry standard of care in the United States, regardless of the payor source - managed care, Medicaid, and Medicare patients alike all require the same service categories," commented Tom Ryan, Chairman of the American Association for Homecare and CEO of Homecare Concepts in Farmingdale, NY.
Oxygen Therapy
Medical oxygen and oxygen systems require a physician's prescription. Oxygen is highly regulated by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration, and the U.S. Department of Transportation.
Oxygen therapy is critical to approximately one million Americans who suffer from respiratory illnesses such as COPD and who require oxygen therapy under Medicare. Nationwide, as many as 15 million Americans have been diagnosed with COPD, which is growing in prevalence. It is a slowly progressive, incurable disease that causes irreversible loss of lung function. Though existing medications have not proven beneficial in reversing its effects, home oxygen therapy-when properly prescribed and maintained-can slow or stop lung degeneration.
Congressional Action on Oxygen Issues
The American Association for Homecare has endorsed the Home Oxygen Patient Protection Act, H.R. 5513, which was introduced in May by two physicians in Congress - Rep. Joe Schwarz (R-Mich.) and Rep. Tom Price (R-Ga.) along with other members of Congress and its Senate companion bill, S. 3814, introduced by Sen. Pat Roberts (R-Kan.) and Sen. Jack Reed (D-R.I.). The bill restores the Medicare treatment of ownership of oxygen equipment to that in effect before enactment of the Deficit Reduction Act of 2005 (DRA). A provision in the DRA forces oxygen users to assume ownership of and responsibility for the oxygen system they use after 36 months. The DRA policy change effectively severs the patient-provider relationship for home oxygen therapy, which raises numerous patient-safety concerns.
The American Association for Homecare, the American Lung Association, and other patient and provider groups vigorously oppose the change in oxygen policy. Medical oxygen therapy at home costs an average of $7.62 per day under Medicare. The average hospital cost under Medicare is $4,603 per day.
"We believe that Congress inadvertently overlooked important patient and public safety concerns associated with home oxygen therapy, and that the new oxygen equipment ownership provisions may actually conflict with existing FDA regulations," said Ryan. "A national Medicare policy that does not account for the many services associated with oxygen therapy shortchanges both the patient and the provider. As a result, up to a million Medicare patients who require medical oxygen may find breathing even harder than it already is."
Ryan continued, "Home oxygen reimbursements under Medicare have been cut by nearly 50 percent over the past decade. This direction in policy will shrink and erode the nation's homecare infrastructure, which delivers high-quality, cost-effective care to a growing population of older Americans."
In a letter to Members of Congress earlier this year, American Lung Association President John Kirkwood said that the DRA provision raises many quality of care, continuity of care and patient out-of-pocket costs issues that may have significant impact on the lives of people with lung disease. "The American Lung Association is deeply troubled that Congress is acting precipitously without enough information to inform lung disease patients of the impact of these proposed changes," Kirkwood wrote. "We urge Congress to ensure these changes will not adversely impact patient health, interrupt continuity of care or shift additional costs to patients and their families."
The American Association for Homecare (AAHomecare) is the only national association that represents every line of service in the homecare community, including home medical equipment providers, respiratory therapy, infusion therapy, rehab and assistive technology, home health agencies, home hospice, and telemedicine. AAHomecare represents more than 3,000 member locations nationwide. For details about home oxygen therapy, see aahomecare.
воскресенье, 15 мая 2011 г.
New Study Demonstrates Rapid Speed Of Onset With Budesonide/formoterol In COPD
New data from a study investigating the
onset of action with respect to airway dilatation in budesonide/formoterol
(Symbicort(R)), salmeterol/fluticasone (SeretideT), salbutamol and placebo
were announced today at the European Respiratory Society 2006 Annual
Congress (ERS)1. The data show that budesonide/formoterol has an onset of
action that is similar to that of salbutamol and faster than that of
salmeterol/fluticasone in patients with COPD.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. Rapid symptom relief from a maintenance treatment will most likely
also provide improved compliance. Therefore the data presented today is very
interesting and adds to our understanding of the role of
budesonide/formoterol in treatment of COPD," said Professor Martyn R.
Partridge, Faculty of Medicine, Imperial College London.
In the double-blind, double-dummy, placebo-controlled crossover study, 88
patients were randomised to four treatments to receive either single doses
of budesonide/formoterol, salmeterol/fluticasone, salbutamol or placebo in
order to compare the onset of action in patients with COPD. Treatments were
administered via pressurised metered dose inhalers (pMDI)*. The primary
endpoint was an improvement in airway dilatation measured by a change in
FEV1 at 5 minutes after inhalation.
The study showed that budesonide/formoterol improved FEV1 to a greater
extent than placebo and that the onset of effect with budesonide/formoterol
was similar to that seen with reliever therapy salbutamol and faster than
salmeterol/fluticasone. Maximal effect on Inspiratory Capacity, regarded as
predictor of exercise tolerance, was greater with budesonide/formoterol as
compared to salmeterol/fluticasone. Improvement in lung function parameters
for all three active treatments was superior to placebo after 180 minutes,
but the two combination treatments were better than the SABA alone at
maintaining the improvement in FEV1.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. The findings from the study confirm that rapid onset of action can
also be exerted by maintenance therapies in COPD," concluded Martyn R.
Partridge.
* Budesonide/formoterol is licensed for use in COPD patients with an
FEV1
onset of action with respect to airway dilatation in budesonide/formoterol
(Symbicort(R)), salmeterol/fluticasone (SeretideT), salbutamol and placebo
were announced today at the European Respiratory Society 2006 Annual
Congress (ERS)1. The data show that budesonide/formoterol has an onset of
action that is similar to that of salbutamol and faster than that of
salmeterol/fluticasone in patients with COPD.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. Rapid symptom relief from a maintenance treatment will most likely
also provide improved compliance. Therefore the data presented today is very
interesting and adds to our understanding of the role of
budesonide/formoterol in treatment of COPD," said Professor Martyn R.
Partridge, Faculty of Medicine, Imperial College London.
In the double-blind, double-dummy, placebo-controlled crossover study, 88
patients were randomised to four treatments to receive either single doses
of budesonide/formoterol, salmeterol/fluticasone, salbutamol or placebo in
order to compare the onset of action in patients with COPD. Treatments were
administered via pressurised metered dose inhalers (pMDI)*. The primary
endpoint was an improvement in airway dilatation measured by a change in
FEV1 at 5 minutes after inhalation.
The study showed that budesonide/formoterol improved FEV1 to a greater
extent than placebo and that the onset of effect with budesonide/formoterol
was similar to that seen with reliever therapy salbutamol and faster than
salmeterol/fluticasone. Maximal effect on Inspiratory Capacity, regarded as
predictor of exercise tolerance, was greater with budesonide/formoterol as
compared to salmeterol/fluticasone. Improvement in lung function parameters
for all three active treatments was superior to placebo after 180 minutes,
but the two combination treatments were better than the SABA alone at
maintaining the improvement in FEV1.
"Speed of onset is as important in COPD as it is in asthma, especially in
the morning when patients often require a rapid onset of bronchodilatory
effect. The findings from the study confirm that rapid onset of action can
also be exerted by maintenance therapies in COPD," concluded Martyn R.
Partridge.
* Budesonide/formoterol is licensed for use in COPD patients with an
FEV1
Spiriva(R) Consistently Reduces Exacerbations And Associated Hospitalisations In Patients With COPD - Meta-Analysis Of Clinical Studies Shows
Patients with chronic obstructive pulmonary disease (COPD) treated with Spiriva(R) (tiotropium) for 6-12 months experienced significantly fewer exacerbations and hospitalisations compared with patients receiving placebo according to an analysis of pooled studies presented today at the International Conference of the American Thoracic Society (ATS).1 Spiriva(R) is the first and only once-daily, inhaled anticholinergic medication for maintenance treatment of COPD.
COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.2 600 million people worldwide already live with COPD, but its prevalence is predicted to rise to become the world's third leading cause of death by 2020.3,4 COPD exacerbations, or an acute worsening of disease symptoms, may accelerate the progression of COPD.2
"These results underline the benefit of effective treatment for patients who suffer with COPD and exacerbations," said Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine at the Royal Devon and Exeter Hospital, UK, and study investigator of the pooled analysis. "Exacerbations of COPD significantly reduce a patient's quality of life, and are a major cause of hospitalisation, disability and death. Preventing and treating exacerbations is a key goal of COPD management."
The post hoc analysis was performed on nine, completed, randomised, placebo-controlled, parallel-group Spiriva(R) studies with a duration of six months to one year.
Exacerbations were uniformly defined across all studies as an increase in, or new onset of at least two of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of three days requiring requiring treatment with antibiotics or systemic steroids, or hospitalisation. 6,171 COPD patients were included in the analysis.
Results showed, compared with placebo1:
-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of COPD exacerbations by 22.6% (65.8 vs. 85.0 per 100 patient-years; p
The Spiriva(R) clinical trials programme has recruited over 25,000 patients.7 Spiriva(R) has demonstrated significant and sustained bronchodilation (opening of the airways)6,8 and reduction in markers of hyperinflation (air trapping).9,10 Spiriva(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ATROVENT(R) (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year6 and has also demonstrated superior improvement in key lung function parameters over salmeterol.11 In addition, in placebo-controlled studies, patients treated with Spiriva(R) had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.8 In clinical trials, the most common adverse reaction reported with Spiriva(R) was dry mouth, which was usually mild and often resolved during treatment.6,8
According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting beta-2-agonists and tiotropium, are a preferred treatment option for COPD maintenance therapy.12
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.
* Exposure was defined as the cumulative time patients participated in the study from randomisation until the onset of exacerbation, or until discontinuation of treatment.
References
1 Halpin D, Menjoge S, Dusser D, et al. Pooled analysis of effect of tiotropium on COPD exacerbations and related hospitalisations. Abstract presented at ATS 2006, San Diego, USA. 19-24 May 2006.
2 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (goldcopd). Updated 2005.
3 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.
4 Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996.
5 Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127:809-817.
6 Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur Respir J 2002; 19:209-216.
7 Boehringer Ingelheim. Data on file.
8 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;1:217-224.
9 Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124:1743-1748.
10 O`Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004 23(6):832-48
11 Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399-404.
12 Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: goldcopd
boehringer-ingelheim
COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.2 600 million people worldwide already live with COPD, but its prevalence is predicted to rise to become the world's third leading cause of death by 2020.3,4 COPD exacerbations, or an acute worsening of disease symptoms, may accelerate the progression of COPD.2
"These results underline the benefit of effective treatment for patients who suffer with COPD and exacerbations," said Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine at the Royal Devon and Exeter Hospital, UK, and study investigator of the pooled analysis. "Exacerbations of COPD significantly reduce a patient's quality of life, and are a major cause of hospitalisation, disability and death. Preventing and treating exacerbations is a key goal of COPD management."
The post hoc analysis was performed on nine, completed, randomised, placebo-controlled, parallel-group Spiriva(R) studies with a duration of six months to one year.
Exacerbations were uniformly defined across all studies as an increase in, or new onset of at least two of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of three days requiring requiring treatment with antibiotics or systemic steroids, or hospitalisation. 6,171 COPD patients were included in the analysis.
Results showed, compared with placebo1:
-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of COPD exacerbations by 22.6% (65.8 vs. 85.0 per 100 patient-years; p
The Spiriva(R) clinical trials programme has recruited over 25,000 patients.7 Spiriva(R) has demonstrated significant and sustained bronchodilation (opening of the airways)6,8 and reduction in markers of hyperinflation (air trapping).9,10 Spiriva(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ATROVENT(R) (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year6 and has also demonstrated superior improvement in key lung function parameters over salmeterol.11 In addition, in placebo-controlled studies, patients treated with Spiriva(R) had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.8 In clinical trials, the most common adverse reaction reported with Spiriva(R) was dry mouth, which was usually mild and often resolved during treatment.6,8
According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting beta-2-agonists and tiotropium, are a preferred treatment option for COPD maintenance therapy.12
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.
* Exposure was defined as the cumulative time patients participated in the study from randomisation until the onset of exacerbation, or until discontinuation of treatment.
References
1 Halpin D, Menjoge S, Dusser D, et al. Pooled analysis of effect of tiotropium on COPD exacerbations and related hospitalisations. Abstract presented at ATS 2006, San Diego, USA. 19-24 May 2006.
2 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (goldcopd). Updated 2005.
3 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.
4 Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996.
5 Casaburi R, Kukafka D, Cooper CB, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127:809-817.
6 Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur Respir J 2002; 19:209-216.
7 Boehringer Ingelheim. Data on file.
8 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;1:217-224.
9 Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124:1743-1748.
10 O`Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004 23(6):832-48
11 Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399-404.
12 Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: goldcopd
boehringer-ingelheim
Positive Results Of Clinical Studies For Aclidinium Bromide, A Novel Long-Acting Anticholinergic For The Treatment For COPD
Laboratorios Almirall, S.A. and Forest Laboratories, Inc. presented
results from four clinical trials assessing the efficacy and
safety of aclidinium bromide, an investigational treatment for chronic
obstructive pulmonary disease (COPD). Data from four preclinical studies
further describing the properties of aclidinium were also presented at the
meeting.
Presentations included data from a 464-patient randomized,
double-blind, four-week, Phase IIb study that evaluated both the efficacy and
tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or
400 mcg) or placebo in patients with moderate to severe COPD. An open-label
tiotropium (18 mcg) arm was included as an active control. The study
demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose
dry powder inhaler, significantly increased trough (24 hour) forced
expiratory volume in one second (FEV1) - an important measure of lung
function - on Day 29 compared with placebo (p
"There are still significant unmet needs in the treatment of
COPD. These efficacy and safety data from the Phase II trials are very
encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer of Forest Laboratories. "We look forward to the completion
of ACCLAIM I & II trials and continuing the clinical development of
aclidinium for the treatment of COPD."
Results of pre-clinical animal and in vitro studies announced
at the meeting showed that aclidinium exhibited low potential for
cardiovascular effects and was broken down in the plasma within 1.8 to 38
minutes, across the models studied.(5) In addition, aclidinium had a potent
and long-lasting effect on preventing bronchoconstriction in both the human
bronchi and several animal models assessed. (6),(7)
Abstracts from ATS 2008 will be available upon request.
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic
bronchodilator that is currently in phase III clinical development as a
once-daily maintenance treatment for COPD. Almirall licensed US rights to
aclidinium to Forest Laboratories, whilst keeping rights for the rest of the
world. The companies are jointly involved in the development of the compound.
About COPD
COPD is a preventable and treatable lung disease characterized
by chronic airflow limitation that interferes with normal breathing and is
not fully reversible.(8) Globally, an estimated 80 million people have
moderate to severe COPD. In excess of 3 million people died of the condition
in 2005, accounting for 5% of all deaths worldwide.(9)
About Almirall
Almirall, an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona, Spain,
researches, develops, manufactures and commercialises its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research
resources are related to the treatment of COPD (Chronic Obstructive Pulmonary
Disease), asthma, psoriasis, rheumatoid arthritis and multiple sclerosis.
Almirall's medicines are currently present in over 70
countries with direct presence in Europe and Latin America.
almirall
About Forest Laboratories
Forest Laboratories is a U.S.-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation; and Bystolic(R) (nebivolol), a beta-adrenergic
receptor blocking agent indicated for the treatment of hypertension. For more
information, visit frx.
* Campral is a registered trademark of Merck Sant?© s.a.s., a subsidiary
of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and launch
of new products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
References
(1) Chanez P, Burge S, Dahl R, et al. Once-daily administration of
aclidinium bromide, a novel, long-acting anticholinergic: a Phase II, dose
finding study. American Thoracic Society, May 2008. Poster.
(2) Lasseter KC, Aubets J, Gil E Garcia. Aclidinium bromide, a novel
long-acting anticholingergic, does not affect QT interval in health subjects.
American Thoracic Society, May 2008. Poster.
(3) Ferrer P, Jansat JM, Gil E Garcia. Pharmokinetics and safety of
aclidinium bromide, a novel long-acting, inhaled anticholinergic, in healthy
subjects. American Thoracic Society, May 2008. Poster.
(4) De Miquel G, Schr?¶dter A, Miletzki B, et al. Low systemic exposure to
aclidinium bromide, a novel long-acting anticholinergic, after multiple
doses. American Thoracic Society, May 2008. Poster.
(5) Gras J, Gavald? A, Llenas J. The preclinical cardiovascular safety
profile of aclidinium bromide, a novel long-acting anticholinergic drug.
American Thoracic Society, May 2008. Poster.
(6) Miralpeix M, Otal R, Carre?±o C, et al. Aclidinium bromide, a novel
anti-muscarinic, reverses cholinergic-induced bronchoconstriction with a fast
onset of action and a long-lasting effect in guinea pigs. American Thoracic
Society, May 2008. Poster.
(7) Cortijo J, Sarri?? B, Gavald? A. In vitro characterization of
aclidinium bromide, a novel long-acting anticholinergic: effects on isolated
human bronchi. American Thoracic Society, May 2008. Poster.
(8) Global Initiative for Chronic Obstructive Lung Disease. Global
strategy for diagnosis, management, prevention of COPD
(goldcopd) accessed 3 September 2007.
(9) World Health Organisation (WHO). Chronic obstructive pulmonary
disease (COPD). Factsheet number 315; November 2006.
almirall
View drug information on Campral.
results from four clinical trials assessing the efficacy and
safety of aclidinium bromide, an investigational treatment for chronic
obstructive pulmonary disease (COPD). Data from four preclinical studies
further describing the properties of aclidinium were also presented at the
meeting.
Presentations included data from a 464-patient randomized,
double-blind, four-week, Phase IIb study that evaluated both the efficacy and
tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or
400 mcg) or placebo in patients with moderate to severe COPD. An open-label
tiotropium (18 mcg) arm was included as an active control. The study
demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose
dry powder inhaler, significantly increased trough (24 hour) forced
expiratory volume in one second (FEV1) - an important measure of lung
function - on Day 29 compared with placebo (p
"There are still significant unmet needs in the treatment of
COPD. These efficacy and safety data from the Phase II trials are very
encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer of Forest Laboratories. "We look forward to the completion
of ACCLAIM I & II trials and continuing the clinical development of
aclidinium for the treatment of COPD."
Results of pre-clinical animal and in vitro studies announced
at the meeting showed that aclidinium exhibited low potential for
cardiovascular effects and was broken down in the plasma within 1.8 to 38
minutes, across the models studied.(5) In addition, aclidinium had a potent
and long-lasting effect on preventing bronchoconstriction in both the human
bronchi and several animal models assessed. (6),(7)
Abstracts from ATS 2008 will be available upon request.
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic
bronchodilator that is currently in phase III clinical development as a
once-daily maintenance treatment for COPD. Almirall licensed US rights to
aclidinium to Forest Laboratories, whilst keeping rights for the rest of the
world. The companies are jointly involved in the development of the compound.
About COPD
COPD is a preventable and treatable lung disease characterized
by chronic airflow limitation that interferes with normal breathing and is
not fully reversible.(8) Globally, an estimated 80 million people have
moderate to severe COPD. In excess of 3 million people died of the condition
in 2005, accounting for 5% of all deaths worldwide.(9)
About Almirall
Almirall, an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona, Spain,
researches, develops, manufactures and commercialises its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research
resources are related to the treatment of COPD (Chronic Obstructive Pulmonary
Disease), asthma, psoriasis, rheumatoid arthritis and multiple sclerosis.
Almirall's medicines are currently present in over 70
countries with direct presence in Europe and Latin America.
almirall
About Forest Laboratories
Forest Laboratories is a U.S.-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation; and Bystolic(R) (nebivolol), a beta-adrenergic
receptor blocking agent indicated for the treatment of hypertension. For more
information, visit frx.
* Campral is a registered trademark of Merck Sant?© s.a.s., a subsidiary
of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and launch
of new products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
References
(1) Chanez P, Burge S, Dahl R, et al. Once-daily administration of
aclidinium bromide, a novel, long-acting anticholinergic: a Phase II, dose
finding study. American Thoracic Society, May 2008. Poster.
(2) Lasseter KC, Aubets J, Gil E Garcia. Aclidinium bromide, a novel
long-acting anticholingergic, does not affect QT interval in health subjects.
American Thoracic Society, May 2008. Poster.
(3) Ferrer P, Jansat JM, Gil E Garcia. Pharmokinetics and safety of
aclidinium bromide, a novel long-acting, inhaled anticholinergic, in healthy
subjects. American Thoracic Society, May 2008. Poster.
(4) De Miquel G, Schr?¶dter A, Miletzki B, et al. Low systemic exposure to
aclidinium bromide, a novel long-acting anticholinergic, after multiple
doses. American Thoracic Society, May 2008. Poster.
(5) Gras J, Gavald? A, Llenas J. The preclinical cardiovascular safety
profile of aclidinium bromide, a novel long-acting anticholinergic drug.
American Thoracic Society, May 2008. Poster.
(6) Miralpeix M, Otal R, Carre?±o C, et al. Aclidinium bromide, a novel
anti-muscarinic, reverses cholinergic-induced bronchoconstriction with a fast
onset of action and a long-lasting effect in guinea pigs. American Thoracic
Society, May 2008. Poster.
(7) Cortijo J, Sarri?? B, Gavald? A. In vitro characterization of
aclidinium bromide, a novel long-acting anticholinergic: effects on isolated
human bronchi. American Thoracic Society, May 2008. Poster.
(8) Global Initiative for Chronic Obstructive Lung Disease. Global
strategy for diagnosis, management, prevention of COPD
(goldcopd) accessed 3 September 2007.
(9) World Health Organisation (WHO). Chronic obstructive pulmonary
disease (COPD). Factsheet number 315; November 2006.
almirall
View drug information on Campral.
Flu Vaccines Can Reduce Respiratory Problems By Up To Three-Quarters
Annual flu vaccinations are highly effective at preventing acute respiratory illness and
making sure that existing breathing problems don't get any worse, according to
research published in the April issue of IJCP, the UK-based International Journal of
Clinical Practice.
A study of 87 patients with chronic obstructive pulmonary disease (COPD) - a major
cause of ill health and death - found that having the annual flu vaccine reduced
overall problems by more than two-thirds.
The vaccinations were particularly effective at providing protection for patients with
severe COPD, where the incidence of additional respiratory problems fell by threequarters.
"COPD is a serious lung disease that causes breathing problems and is responsible
for a significant number of outpatient and emergency department visits as well as
inpatient hospital stays" says lead author Dr Balakrishnan Menon from the
Vallabhbhai Patel Chest Institute at the University of Delhi, India.
"It has increased by 40 per cent since 1942 and is now the world's fourth leading
cause of death and twelfth leading cause of disability. The World Health Organization
(WHO) predicts that by 2020 it will become the third leading cause of death and rise
significantly in the disability stakes to fifth place.
"Most of the healthcare costs associated with COPD are due to problems that worsen
the condition and infections caused by the influenza virus are major culprits.
"Despite the WHO's recommendation that all patients with COPD should receive the
annual flu vaccine, the injection is not used as widely as it could be, especially in
developing countries.
"Our research suggests that this could be leading to higher levels of respiratory
problems and that these extra healthcare costs could be avoided by improving the
uptake of this simple preventative measure."
The 87 male patients, who had an average age of just under 65, were monitored for
a year before and after they received the vaccine. All had been diagnosed with
COPD, but none of them had previously received the flu vaccine.
After the patients received the vaccine, the overall incidence of acute respiratory
illness and acute exacerbation of COPD fell by 67 per cent, with 24 patients
experiencing them before they received the vaccinee and eight experiencing them in
the post-vaccination period.
The effectiveness of the vaccine varied, depending on how badly people suffered
from the disease. People with mild or moderate COPD saw a 60 per cent reduction in
overall incidence and people with severe COPD enjoyed a 75 per cent reduction.
Outpatient visits fell by 50 per cent after vaccination and there was also a 70 per cent
reduction in the number of study participants who were hospitalised.
During the two-year study period patients attended monthly check-ups and received
the same level of medication, healthcare and lifestyle advice. Any respiratory
problems were also carefully monitored.
The researchers were careful to ensure that no other factors clouded the results so
that they could observe the effect of the influenza virus more efficiently. This included
having an all male study group. Fewer women met the study criteria, mainly because
they were less likely to smoke ??????" 83 per cent of the men in this study were current or
former smokers.
"Influenza viruses are a major cause of death and serious illness in elderly people,
particularly if they suffer from COPD" concludes Dr Menon.
"Our study was undertaken in a population where uptake of the vaccine is
traditionally low and it had a marked effect on the men who received it. This could
also explain why our 67 per cent reduction was higher than the 32 to 45 per cent falls
reported by previous studies carried out in populations where the vaccine is more
common.
"We believe that our research underlines the importance of increasing vaccine use
worldwide, especially in patients with COPD and in areas where the flu vaccination
rate is low.
"It is clear that annual flu vaccinations have a major role to play in bringing down the
number of preventable deaths and hospital admissions that occur every year in
patients with chronic lung diseases."
"Comparison of outpatient visits and hospitalisations in patients with chronic obstructive
pulmonary disease, before and after influenza vaccination". Menon et al. IJCP, the
International Journal of Clinical Practice. 62.4, pp 593-598.
IJCP, the International Journal of Clinical Practice was established in 1946 and is edited
by Dr Graham Jackson from Guy's and St Thomas' NHS Foundation Trust, London, UK.
It provides its global audience of clinicians with high-calibre clinical papers, including
original data from clinical investigations, evidence-based analysis and discussions on the
latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the
international Blackwell Publishing group. blackwellpublishing/ijcp
About Wiley-Blackwell
Wiley-Blackwell was formed in February 2007 as a result of the
acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with
Wiley's Scientific, Technical, and Medical business. Together, the companies have
created a global publishing business with deep strength in every major academic and
professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peerreviewed
journals and an extensive collection of books with global appeal. For more
information on Wiley-Blackwell, please visit blackwellpublishing or
interscience.wiley
John Wiley & Sons, Inc.
making sure that existing breathing problems don't get any worse, according to
research published in the April issue of IJCP, the UK-based International Journal of
Clinical Practice.
A study of 87 patients with chronic obstructive pulmonary disease (COPD) - a major
cause of ill health and death - found that having the annual flu vaccine reduced
overall problems by more than two-thirds.
The vaccinations were particularly effective at providing protection for patients with
severe COPD, where the incidence of additional respiratory problems fell by threequarters.
"COPD is a serious lung disease that causes breathing problems and is responsible
for a significant number of outpatient and emergency department visits as well as
inpatient hospital stays" says lead author Dr Balakrishnan Menon from the
Vallabhbhai Patel Chest Institute at the University of Delhi, India.
"It has increased by 40 per cent since 1942 and is now the world's fourth leading
cause of death and twelfth leading cause of disability. The World Health Organization
(WHO) predicts that by 2020 it will become the third leading cause of death and rise
significantly in the disability stakes to fifth place.
"Most of the healthcare costs associated with COPD are due to problems that worsen
the condition and infections caused by the influenza virus are major culprits.
"Despite the WHO's recommendation that all patients with COPD should receive the
annual flu vaccine, the injection is not used as widely as it could be, especially in
developing countries.
"Our research suggests that this could be leading to higher levels of respiratory
problems and that these extra healthcare costs could be avoided by improving the
uptake of this simple preventative measure."
The 87 male patients, who had an average age of just under 65, were monitored for
a year before and after they received the vaccine. All had been diagnosed with
COPD, but none of them had previously received the flu vaccine.
After the patients received the vaccine, the overall incidence of acute respiratory
illness and acute exacerbation of COPD fell by 67 per cent, with 24 patients
experiencing them before they received the vaccinee and eight experiencing them in
the post-vaccination period.
The effectiveness of the vaccine varied, depending on how badly people suffered
from the disease. People with mild or moderate COPD saw a 60 per cent reduction in
overall incidence and people with severe COPD enjoyed a 75 per cent reduction.
Outpatient visits fell by 50 per cent after vaccination and there was also a 70 per cent
reduction in the number of study participants who were hospitalised.
During the two-year study period patients attended monthly check-ups and received
the same level of medication, healthcare and lifestyle advice. Any respiratory
problems were also carefully monitored.
The researchers were careful to ensure that no other factors clouded the results so
that they could observe the effect of the influenza virus more efficiently. This included
having an all male study group. Fewer women met the study criteria, mainly because
they were less likely to smoke ??????" 83 per cent of the men in this study were current or
former smokers.
"Influenza viruses are a major cause of death and serious illness in elderly people,
particularly if they suffer from COPD" concludes Dr Menon.
"Our study was undertaken in a population where uptake of the vaccine is
traditionally low and it had a marked effect on the men who received it. This could
also explain why our 67 per cent reduction was higher than the 32 to 45 per cent falls
reported by previous studies carried out in populations where the vaccine is more
common.
"We believe that our research underlines the importance of increasing vaccine use
worldwide, especially in patients with COPD and in areas where the flu vaccination
rate is low.
"It is clear that annual flu vaccinations have a major role to play in bringing down the
number of preventable deaths and hospital admissions that occur every year in
patients with chronic lung diseases."
"Comparison of outpatient visits and hospitalisations in patients with chronic obstructive
pulmonary disease, before and after influenza vaccination". Menon et al. IJCP, the
International Journal of Clinical Practice. 62.4, pp 593-598.
IJCP, the International Journal of Clinical Practice was established in 1946 and is edited
by Dr Graham Jackson from Guy's and St Thomas' NHS Foundation Trust, London, UK.
It provides its global audience of clinicians with high-calibre clinical papers, including
original data from clinical investigations, evidence-based analysis and discussions on the
latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the
international Blackwell Publishing group. blackwellpublishing/ijcp
About Wiley-Blackwell
Wiley-Blackwell was formed in February 2007 as a result of the
acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with
Wiley's Scientific, Technical, and Medical business. Together, the companies have
created a global publishing business with deep strength in every major academic and
professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peerreviewed
journals and an extensive collection of books with global appeal. For more
information on Wiley-Blackwell, please visit blackwellpublishing or
interscience.wiley
John Wiley & Sons, Inc.
Study Results For Aclidinium Bromide, A Novel Anticholinergic, Presented At European Respiratory Society Annual Congress
Forest
Laboratories (NYSE: FRX) announced that single doses of inhaled
aclidinium produced a significant bronchodilatory response in 17 patients
with COPD according to results of a phase IIa trial presented today at the
European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
Results of the study showed that mean FEV1 and FVC values - important
measures of lung function - were significantly increased with all studied
doses of aclidinium over a 24-hour time period, as compared to placebo.
Onset of significant bronchodilation was observed as early as 15 minutes
after aclidinium treatment and this effect was sustained for at least 24
hours. Forest licensed aclidinium, currently in phase III clinical trials
in COPD, from Spanish pharmaceutical company, Almirall.
Aclidinium was well-tolerated during the phase IIa trial and no
patients withdrew from the study because of adverse events. The majority of
adverse events reported were mild to moderate in intensity. The most
frequent drug- related adverse event observed was headache, which occurred
after both placebo and aclidinium treatment and was not dose-related.
Single doses of aclidinium did not result in any clinically significant
adverse effect on vital signs, heart function (as assessed by 12-lead ECG)
or laboratory data.
"Given the increasing disease burden of COPD in the US, there is a need
for new treatment options for patients suffering from this debilitating
disease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer. "These phase II data reinforce our belief that
aclidinium has the potential to be a significant addition to the existing
armamentarium of COPD treatments."
Methodology
The phase IIa study of aclidinium was a two-center, double-blind,
randomized, ascending single-dose, placebo-controlled, cross-over trial
which enrolled 17 patients with moderate to severe COPD. Treatment was with
one of three doses of aclidinium (100 micrograms, 300 micrograms or 900
micrograms) or placebo-administered via dry-powder inhaler. The study's
primary outcome measure was area under the normalized curve (AUC) of FEV1
over a 24-hour time period.
Findings of a phase I single-dose study, also presented at ERS 2007,
demonstrate the bronchodilatory effects of aclidinium.(2) In the phase I
study, in 12 healthy volunteers, bronchoconstriction was induced with
methacholine challenge and then treated with one of three doses of
aclidinium. Aclidinium proved superior to placebo in improving specific
airway conductance. Aclidinium also provided statistically significant and
sustained protection against methacholine-induced airway constriction over
24 hours. Aclidinium was well-tolerated throughout the trial. Headache was
reported by two subjects and one subject experienced a serious adverse
event which was not considered to be related to study drug.
Results of preclinical studies also presented at the congress show
aclidinium's selectivity, long duration of action and rapid clearance from
the plasma.(3,4) When compared to other bronchodilatory agents in vitro,
aclidinium demonstrated potent anticholinergic activity comparable to both
tiotropium and ipratropium, but with a faster onset of action than
tiotropium and a significantly longer duration of action versus
ipratropium, allowing for 24- hour duration of action.(4)
About COPD
COPD is a preventable and treatable lung disease characterized by
chronic airflow limitation that is not fully reversible.(5) COPD is a
leading cause of death, illness, and disability in the United States, with
an estimated 10 million to 24 million adults in the US living with COPD.(6)
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic bronchodilator
that is currently in phase III clinical development as a once-daily
maintenance treatment for COPD.
About Forest Laboratories and Its Products
Forest Laboratories (frx) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar
HCT(R) (olmesartan medoxomil - hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product, each indicated for the
treatment of hypertension; and Campral(R) (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2007 and quarterly report
on form 10-Q for the period ended June 30, 2007.
References
1. Joos GF, Schelfhout VJ, Kanniess F et al. Bronchodilator effects of
aclidinium bromide, a novel long-acting anticholinergic, in COPD
patients: a phase II study. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
2. Schelfhout VJ, Joos GF, Gil EG et al. Bronchodilator/bronchoprotective
effects of aclidinium bromide, a novel long-acting anticholinergic: a
phase I study. European Respiratory Society (ERS) Annual Congress,
September 2007. Poster.
3. Gavalda A, Miralpeix M, Ramos I et al. Aclidinium bromide, a novel
muscarinic receptor antagonist combining long residence at M3 receptors
and rapid plasma clearance. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
4. Miralpeix M, Gavalda A, Morcillo E et al. Assessment of the potency and
duration of action of aclidinium bromide in guinea pig isolated trachea
in vitro. European Respiratory Society (ERS) Annual Congress, September
2007. Poster.
5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy
for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease; MCR Vision, Inc.; 2006
6. CDC, cdc/nceh/airpollution/copd/copdfaq.htm, accessed
September 11, 2007.
Forest Laboratories
frx
View drug information on Benicar; Campral.
Laboratories (NYSE: FRX) announced that single doses of inhaled
aclidinium produced a significant bronchodilatory response in 17 patients
with COPD according to results of a phase IIa trial presented today at the
European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
Results of the study showed that mean FEV1 and FVC values - important
measures of lung function - were significantly increased with all studied
doses of aclidinium over a 24-hour time period, as compared to placebo.
Onset of significant bronchodilation was observed as early as 15 minutes
after aclidinium treatment and this effect was sustained for at least 24
hours. Forest licensed aclidinium, currently in phase III clinical trials
in COPD, from Spanish pharmaceutical company, Almirall.
Aclidinium was well-tolerated during the phase IIa trial and no
patients withdrew from the study because of adverse events. The majority of
adverse events reported were mild to moderate in intensity. The most
frequent drug- related adverse event observed was headache, which occurred
after both placebo and aclidinium treatment and was not dose-related.
Single doses of aclidinium did not result in any clinically significant
adverse effect on vital signs, heart function (as assessed by 12-lead ECG)
or laboratory data.
"Given the increasing disease burden of COPD in the US, there is a need
for new treatment options for patients suffering from this debilitating
disease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer. "These phase II data reinforce our belief that
aclidinium has the potential to be a significant addition to the existing
armamentarium of COPD treatments."
Methodology
The phase IIa study of aclidinium was a two-center, double-blind,
randomized, ascending single-dose, placebo-controlled, cross-over trial
which enrolled 17 patients with moderate to severe COPD. Treatment was with
one of three doses of aclidinium (100 micrograms, 300 micrograms or 900
micrograms) or placebo-administered via dry-powder inhaler. The study's
primary outcome measure was area under the normalized curve (AUC) of FEV1
over a 24-hour time period.
Findings of a phase I single-dose study, also presented at ERS 2007,
demonstrate the bronchodilatory effects of aclidinium.(2) In the phase I
study, in 12 healthy volunteers, bronchoconstriction was induced with
methacholine challenge and then treated with one of three doses of
aclidinium. Aclidinium proved superior to placebo in improving specific
airway conductance. Aclidinium also provided statistically significant and
sustained protection against methacholine-induced airway constriction over
24 hours. Aclidinium was well-tolerated throughout the trial. Headache was
reported by two subjects and one subject experienced a serious adverse
event which was not considered to be related to study drug.
Results of preclinical studies also presented at the congress show
aclidinium's selectivity, long duration of action and rapid clearance from
the plasma.(3,4) When compared to other bronchodilatory agents in vitro,
aclidinium demonstrated potent anticholinergic activity comparable to both
tiotropium and ipratropium, but with a faster onset of action than
tiotropium and a significantly longer duration of action versus
ipratropium, allowing for 24- hour duration of action.(4)
About COPD
COPD is a preventable and treatable lung disease characterized by
chronic airflow limitation that is not fully reversible.(5) COPD is a
leading cause of death, illness, and disability in the United States, with
an estimated 10 million to 24 million adults in the US living with COPD.(6)
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic bronchodilator
that is currently in phase III clinical development as a once-daily
maintenance treatment for COPD.
About Forest Laboratories and Its Products
Forest Laboratories (frx) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar
HCT(R) (olmesartan medoxomil - hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product, each indicated for the
treatment of hypertension; and Campral(R) (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2007 and quarterly report
on form 10-Q for the period ended June 30, 2007.
References
1. Joos GF, Schelfhout VJ, Kanniess F et al. Bronchodilator effects of
aclidinium bromide, a novel long-acting anticholinergic, in COPD
patients: a phase II study. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
2. Schelfhout VJ, Joos GF, Gil EG et al. Bronchodilator/bronchoprotective
effects of aclidinium bromide, a novel long-acting anticholinergic: a
phase I study. European Respiratory Society (ERS) Annual Congress,
September 2007. Poster.
3. Gavalda A, Miralpeix M, Ramos I et al. Aclidinium bromide, a novel
muscarinic receptor antagonist combining long residence at M3 receptors
and rapid plasma clearance. European Respiratory Society (ERS) Annual
Congress, September 2007. Poster.
4. Miralpeix M, Gavalda A, Morcillo E et al. Assessment of the potency and
duration of action of aclidinium bromide in guinea pig isolated trachea
in vitro. European Respiratory Society (ERS) Annual Congress, September
2007. Poster.
5. Global Initiative for Chronic Obstructive Lung Disease. Global strategy
for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease; MCR Vision, Inc.; 2006
6. CDC, cdc/nceh/airpollution/copd/copdfaq.htm, accessed
September 11, 2007.
Forest Laboratories
frx
View drug information on Benicar; Campral.
Lung Function Decline In Smokers Slowed By Higher Physical Activity Level
Moderate to high levels of regular physical activity are associated with lower lung function decline among smokers and help to moderate their risk of developing chronic obstructive pulmonary disease (COPD), according to a large retrospective cohort study.
The research appears in the first issue for March 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
(A cohort study is one in which a group of subjects are followed over time and compared with another group who are not affected by the condition being studied. Cohort studies are generally preferred to case control studies, since they involve far fewer statistical problems and generally produce more reliable answers.)
Judith Garcia-Aymerich, M.D., Ph.D., of the Center for Research in Environmental Epidemiology at the Institut Municipal d'Investigaci?? M??dica in Barcelona, Spain, and four associates assessed the physical activity, smoking history and lung function of 6,790 persons over 11 years. The investigators excluded individuals with COPD at the study's start.
"Prior to our study, the extent to which regular physical activity could reduce the risk of developing COPD was not known, but both epidemiologic and experimental studies indirectly supported this hypothesis," said Dr. Garcia-Aymerich.
COPD is the fourth-leading cause of death in the United States, killing 122,283 Americans in 2003. It results from chronic bronchitis and emphysema, two lung diseases which frequently co-exist and cause obstruction to airflow that interferes with normal breathing. Smoking is the primary cause of COPD.
Over the course of the 11-year study, 928 patients developed COPD. According to the authors, the reduction in COPD among smokers due to moderate to high levels of physical activity was 21 percent of potential new cases.
The investigators attribute this decline in new cases to regular exercise, which suppresses the production of inflammatory markers in the lungs caused by smoking, and reduces the pathogenesis of COPD.
Until now, smokers' only options for slowing lung function decline included stopping smoking and reducing occupational exposure to smoke. Therefore, Dr. Garcia-Aymerich and colleagues believe that their findings could offer smokers an important alternative.
"The interaction between physical activity and smoking should be taken into account when projecting the future burden of this respiratory disease," said Dr. Garcia-Aymerich.
Contact: Judith Garcia-Aymerich, M.D., Ph.D., Center for Research in Environmental Epidemiology (CREAL), Institut Municipal d'Investigaci?? M??dica (IMIM), Doctor Aiguader 88, 08003 Barcelona, Catalonia, Spain
Contact: Suzy Martin
American Thoracic Society
The research appears in the first issue for March 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
(A cohort study is one in which a group of subjects are followed over time and compared with another group who are not affected by the condition being studied. Cohort studies are generally preferred to case control studies, since they involve far fewer statistical problems and generally produce more reliable answers.)
Judith Garcia-Aymerich, M.D., Ph.D., of the Center for Research in Environmental Epidemiology at the Institut Municipal d'Investigaci?? M??dica in Barcelona, Spain, and four associates assessed the physical activity, smoking history and lung function of 6,790 persons over 11 years. The investigators excluded individuals with COPD at the study's start.
"Prior to our study, the extent to which regular physical activity could reduce the risk of developing COPD was not known, but both epidemiologic and experimental studies indirectly supported this hypothesis," said Dr. Garcia-Aymerich.
COPD is the fourth-leading cause of death in the United States, killing 122,283 Americans in 2003. It results from chronic bronchitis and emphysema, two lung diseases which frequently co-exist and cause obstruction to airflow that interferes with normal breathing. Smoking is the primary cause of COPD.
Over the course of the 11-year study, 928 patients developed COPD. According to the authors, the reduction in COPD among smokers due to moderate to high levels of physical activity was 21 percent of potential new cases.
The investigators attribute this decline in new cases to regular exercise, which suppresses the production of inflammatory markers in the lungs caused by smoking, and reduces the pathogenesis of COPD.
Until now, smokers' only options for slowing lung function decline included stopping smoking and reducing occupational exposure to smoke. Therefore, Dr. Garcia-Aymerich and colleagues believe that their findings could offer smokers an important alternative.
"The interaction between physical activity and smoking should be taken into account when projecting the future burden of this respiratory disease," said Dr. Garcia-Aymerich.
Contact: Judith Garcia-Aymerich, M.D., Ph.D., Center for Research in Environmental Epidemiology (CREAL), Institut Municipal d'Investigaci?? M??dica (IMIM), Doctor Aiguader 88, 08003 Barcelona, Catalonia, Spain
Contact: Suzy Martin
American Thoracic Society
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