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Perforomist-comparable pharmacokinetic and pharmacodynamic profile to DPI formulation
Date:5/20/2008

Napa, CA (May 20, 2008) Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist™ 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® Aerolizer® 12 g (FA).

Perforomist™ (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 20 g of FFIS (Perforomist™ 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™ 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™ 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™ Inhalation Solution comparable to that of the marketed DPI, Foradil® Aerolizer®. Mean FEV1 AUC0-12 (standardized area under the curve for FEV1 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™ Inhalation Solution 20 g and Foradil® Aerolizer®. 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 24 g with Foradil® Aerolizer®, which confirmed pharmacokinetic comparability between Perforomist™ Inhalation Solution 20 g by nebulization and Foradil® Aerolizer® 12 g (Foradil) by DPI.

This research continues to support and highlight the clinical value of Perforomist™ 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.


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Contact: Amy Techtmann
amy.techtmann@fkhealth.com
617-761-6784
Feinstein Kean Healthcare
Source:Eurekalert

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