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Concomitant Treatment With Nebulized Formoterol Fumarate and Tiotropium Provides Clinically Significant Improvements for COPD Patients
Date:5/20/2008

- Study shows significantly improved bronchodilation and symptom control

with combination therapy -

NAPA, Calif., May 20 /PRNewswire/ -- A newly published study presents data demonstrating that patients with Chronic Obstructive Pulmonary Disease (COPD), including emphysema and chronic bronchitis, experienced markedly improved bronchodilation and symptom control when treated with a combination of nebulized formoterol fumarate inhalation solution (Perforomist(TM) Inhalation Solution) and tiotropium (TIO), compared to treatment with tiotropium alone. The two medications, when used adjunctively, were also well tolerated by patients over the course of the 6-week study.

"Concomitant Treatment with Nebulized Formoterol and Tiotropium in Subjects with COPD: A Placebo-Controlled Trial," published in Respiratory Medicine, assesses the efficacy and safety of the concomitant treatment of Perforomist(TM) nebulized formoterol fumarate (a long-acting beta-agonist [LABA]) and tiotropium (an anticholinergic) in 130 adults with moderate to severe COPD.

"These data provide additional insight into the additive benefit of concomitant therapy with a LABA and a long-acting anticholinergic," said Dr. Donald Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles, lead author and principal investigator of the study. "When Perforomist(TM) Solution's rapid onset of action is combined with tiotropium's prolonged bronchodilation, the result appears to be a safe and effective treatment option for patients. This is great news for the millions of patients -- and their families -- who live with COPD, and who too often struggle with an insufficient number of robust treatment options."

About the Study

The study was a six-week, randomized, double-blind, placebo-controlled, parallel-group design study. COPD patients entered a 7-14 day run-in period during which subjects received once-daily treatment with tiotropium bromide inhalation powder (TIO; Spiriva(R), 18mcg) administered with a HandiHaler(R). Following randomization, subjects entered a six-week treatment period to evaluate the safety and efficacy of formoterol fumarate inhalation solution (FFIS; Perforomist(TM), 20mcg/2mL) while maintaining once-daily treatment with TIO. The primary efficacy endpoint was standardized area under the curve for FEV(1) over three hours (FEV(1) AUC(0-3)) at the last visit (week 6).

The standardized absolute AUC(0-3) for FEV(1) following the first dose of study medication at Day 1 was statistically significantly improved in the Perforomist(TM)/TIO group compared with placebo/TIO group (PLA/TIO). FEV(1) AUC(0-3) remained significantly greater in the Perforomist(TM)/TIO group after six weeks without any decrease of effect or evidence of tolerance (p< 0.0001). Peak FEV(1) levels were significantly higher in the Perforomist(TM)/TIO group compared with PLA/TIO (p< 0.0001). Symptoms, including shortness of breath, chest tightness, night-time awakenings, and the total respiratory symptom score, were all significantly improved in the Perforomist(TM)/TIO group compared with PLA/TIO. Use of albuterol rescue medication declined in the Perforomist(TM)/TIO group and remained low throughout the treatment, whereas albuterol use in the PLA/TIO group trended higher through the six weeks of treatment (p<0.0001), suggesting enhanced control of COPD symptoms.

Quality of life was assessed with St. George's Respiratory Questionnaire (SGRQ), the results of which were similar at day 1 and did not change markedly over the six weeks of treatment. The only statistically significant and clinically relevant treatment difference observed with Perforomist(TM)/TIO compared with PLA/TIO was an improvement in symptom score (LS mean change of - 5.8 units).

Other Recently Published Data

Results from the Phase III pivotal trial of Perforomist(TM) (formoterol fumarate) Inhalation Solution, the first and only FDA-approved nebulized formoterol fumarate, were also recently published. Perforomist(TM) Inhalation Solution is indicated for long-term, twice-daily maintenance treatment of COPD.

-- "Efficacy and Safety of Formoterol Fumarate Delivered by Nebulization

to COPD Patients," published in the February 2008 issue of Respiratory

Medicine, detailed pivotal Phase III data that supported the NDA

approval for Perforomist(TM) (formoterol fumarate) Inhalation Solution.

The study demonstrated that Perforomist(TM) Inhalation Solution has a

rapid onset of significant bronchodilation within five minutes of

administration and is safe and effective. The study assessed the

efficacy and safety of Perforomist(TM) Inhalation Solution in 351

adults with moderate-to-severe COPD. Nicholas J. Gross, MD, PhD, Hines

VA Hospital, Stricht Loyola School of Medicine, was lead author and

principal investigator of the study.

-- In October 2007, Clinical Therapeutics published cardiac safety results

from the Phase III trial for Perforomist(TM) Inhalation Solution. In

"Cardiac Safety Profile of Nebulized Formoterol in Adults with COPD: A

12-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-

and Active-Controlled Trial," the data showed that Perforomist(TM)

Inhalation Solution was associated with rapid and sustained improvement

in pulmonary function with no clinically significant cardiac effects,

including QT prolongation, increased proarrhythmic events, or changes

in serum potassium levels. Harold S. Nelson, MD, Professor of

Medicine, National Jewish Medical and Research Center; was lead author

of the article and principal investigator of the study. Patients with

cardiac problems were excluded from the study. Perforomist(TM) should

be used with caution in patients with cardiovascular disorders,

especially coronary insufficiency, cardiac arrythmias, and

hypertension.

Funding for these studies was provided by Dey, L.P., manufacturer and marketer of Perforomist(TM) (formoterol fumarate) Inhalation Solution. Perforomist(TM) Inhalation Solution is the first and only FDA-approved nebulized form of formoterol fumarate. Formoterol fumarate is a rapid and long-acting beta(2)-agonist (LABA) that has been previously available in the U.S. in a dry powder formulation with twenty years of worldwide experience. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or facemask.

"Taken together, these studies expand our understanding of the clinical benefits of Perforomist(TM) Inhalation Solution for the treatment of COPD," said Carolyn Myers, Ph.D., President of Dey, L.P. "Perforomist Inhalation Solution offers physicians a flexible, safe, and highly effective treatment option for COPD -- and many patients may benefit from this new addition to the treatment armamentarium."

About Perforomist(TM) Inhalation Solution

Indication

Perforomist(TM) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

Perforomist(TM) Inhalation Solution belongs to a class of medications known as long-acting beta(2)-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist(TM) Inhalation Solution.

Perforomist(TM) Inhalation Solution should not be used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist(TM) Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist(TM) Inhalation Solution should be used with caution in patients with cardiovascular disorders. Perforomist(TM) Inhalation Solution is not a substitute for inhaled or oral corticosteroids. The safety and efficacy of Perforomist(TM) Inhalation Solution in asthma has not been established.

In COPD clinical trials, the most common adverse events reported with Perforomist(TM) Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Please see full Prescribing Information, including Boxed Warning, at http://www.perforomist.com or call 800-755-5560 and ask for Customer Service.

About COPD(1)

COPD refers to a number of chronic lung disorders in which the airways to the lungs become narrowed and breathing becomes increasingly difficult. The most common forms of COPD are chronic bronchitis and emphysema and many patients suffer from a combination of the two diseases.

COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. Twelve million Americans have been diagnosed with COPD and at least another 12 million have symptoms that have not been diagnosed. COPD is not well understood or recognized -- most Americans have not heard of it, not even those who may be living with the condition. The most common cause of COPD is cigarette smoking, which is responsible for an estimated 80 to 90 percent of COPD cases. Estimates of the total incidence of COPD in America range from 24 to 30 million.

About Nebulization

Of the three types of devices used to deliver bronchodilators -- nebulizers, metered-dose inhalers, and dry powder inhalers -- nebulizers require no special technique or coordination, as the medication is converted into a fine mist that the patient inhales through a mouthpiece or face-mask while breathing naturally.(2) Nebulization is an easy and effective method of delivering medicine directly into the lungs for patients, particularly as their symptoms worsen.(3)

With Perforomist(TM) Inhalation Solution, nebulization may become a more widely used treatment option for many COPD patients at earlier treatment stages who could benefit from twice-daily maintenance dosing of a nebulized LABA such as Perforomist(TM) Inhalation Solution. For example, this new COPD treatment may be a valuable clinical option for many patients whose symptoms are not adequately controlled with their current therapy.(4) COPD patients may consider asking their doctor whether nebulized treatment may be right for them.

About Dey, L.P.

Dey, L.P., a subsidiary of Mylan Inc. (NYSE: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, respiratory-related allergies, and emergency care medicine. As the U.S. leader in sales of nebulized respiratory medication, Dey, L.P. puts patients first through its development of innovative and affordable therapies. The Web sites for Dey, L.P. include http://www.dey.com, http://www.accuneb.com, http://www.curosurfusa.com, http://www.cyanokit.com, http://www.duoneb.com, http://www.epipen.com and http://www.perforomist.com.

Perforomist(TM) is a trademark of Dey, L.P.

Spiriva(R) is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc.

HandiHaler(R) is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc.

(1) National Heart Lung and Blood Institute. COPD: Are you at Risk? Fact

Sheet. Available at http://www.nhlbi.nih.gov/health/public/lung/copd/campaign-materials/index.htm (2) WebMD. "A-Z Health Guide from WebMD." Accessed on May 9, 2006 from http://www.webmd.com/hw/health_guideatoz/stn166150.asp?navbar=hw32561.
(3) Ibid

(4) Gross, N. et. al. Efficacy and safety of formoterol fumarate delivered

by nebulization to COPD patients. Respiratory Medicine, 2008, 102,

189-197

Media contacts: Dey, L.P. Media Line

1-800-755-5560 ext. 8363

or

Amy Techtmann

Feinstein Kean Healthcare

617-761-6784

amy.techtmann@fkhealth.com


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SOURCE Dey, L.P.
Copyright©2008 PR Newswire.
All rights reserved

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