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Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic Profile to Dry Powder Formulation
Date:5/20/2008

- Data from two clinical trials presented at International ATS Conference -

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 diffic
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SOURCE Dey L.P.
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