Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic Profile to Dry Powder Formulation

NAPA, Calif., May 20 /PRNewswire/ -- Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist(TM) Inhalation Solution (formoterol fumarate inhalation solution; FFIS) has a pharmacodynamic and pharmacokinetic profile that is comparable to the dry powder inhaler (DPI) formulation of formoterol fumarate, Foradil(R) Aerolizer(R) 12mcg (FA).

Perforomist(TM) (formoterol fumarate) Inhalation Solution, the only FDA- approved nebulized formoterol fumarate, was approved in 2007 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The first of the two studies presented, "Dose-Ranging Study in COPD Patients Comparing Pharmacodynamics of Formoterol Fumarate Delivered by Nebulization and DPI," showed that 20mcg of FFIS (Perforomist(TM) Inhalation Solution) delivered by nebulization provides bronchodilation comparable to DPI delivery.

The second study; "A Pharmacokinetic Study in COPD Patients Comparing Formoterol Fumarate Delivered by Nebulization and DPI," showed comparability in linear kinetics and excreted drug levels between formoterol fumarate administered by nebulization and DPI. Transient and dose-related effects on serum potassium, serum glucose and vital signs were observed and found to be comparable between the two formulations.

Dr. Nicholas J. Gross, MD, PhD, Hines VA Hospital, Stricht Loyola School of Medicine and lead clinical investigator in the first study, commented, "The results of both of these studies provide additional evidence of the clinical benefit of Perforomist(TM) Inhalation Solution as a valuable treatment option for patients with COPD. Nebulization is an alternative way to deliver medication to the lungs and since many patients may have difficulty coordinating the use of other devices as their disease progresses, nebulized Perforomist(TM) offers an effective, long-term treatment option."

The first study was a single-dose, double-blind, double-dummy crossover dose-ranging study conducted in 47 patients to establish the dose of Perforomist(TM) Inhalation Solution comparable to that of the marketed DPI, Foradil(R) Aerolizer(R). Mean FEV(1) AUC(0-12) (standardized area under the curve for FEV(1) over twelve hours) following FFIS treatment ranged from 1.3 to 3.0 L/hr in a dose-related manner, with identical values (2.3 L/hr) for Perforomist(TM) Inhalation Solution 20mcg and Foradil(R) Aerolizer(R). All other spirometry measures were comparable between FFIS and FA.

The second study involving thirteen COPD patients was a randomized, single-dose, open-label, crossover study comparing FFIS 10, 20, and 24mcg with Foradil(R) Aerolizer(R), which confirmed pharmacokinetic comparability between Perforomist(TM) Inhalation Solution 20mcg by nebulization and Foradil(R) Aerolizer(R) 12mcg (Foradil) by DPI.

"This research continues to support and highlight the clinical value of Perforomist(TM) Inhalation Solution," said Carolyn Myers, Ph.D., President of Dey, L.P. "We thank all of these eminent researchers for their contributions to the trials that were presented today and we remain dedicated to developing nebulized treatment options for those suffering from serious respiratory illnesses such as COPD."

For those attending ATS 2008, the presentations are available as follows: Poster viewing: Session ID C42 COPD Pharmacotherapy I: Effects of Bronchodilators Tuesday, May 20, 2008, 10:45 a.m. - 12:30 p.m. EDT Metro Toronto Convention Center; Area F: Halls A-B North Building, Level 300 -- Poster #F13: Dose-Ranging Study in COPD Patients Comparing Pharmacodynamics of Formoterol Fumarate Delivered by Nebulization and DPI -- Poster #F14: A Pharmacokinetic Study in COPD Patients Comparing Formoterol Fumarate Delivered by Nebulization and DPI

The research presented at ATS 2008 was supported through grants provided by Dey, L.P., which developed and markets Perforomist(TM) Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. .

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 but 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 should consider asking their doctor whether nebulized treatment may be right for them.

About Dey, L.P.

Dey, L.P., a subsidiary of Mylan Inc. , 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. Foradil(R) Aerolizer(R) is a registered trademark of Novartis Pharma AG (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