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FDA approves Dey, L.P.'s Perforomist inhalation solution for maintenance treatment of COPD

Director, Pulmonary, Critical Care and Respiratory Service, Washington Hospital Service, commented, "In my clinical experience, formoterol has been shown over many years to be an extremely effective clinical option for many COPD patients. It is a proven, well-understood compound whose fast onset of action combined with sustained symptomatic relief is highly stabilizing for many patients, offering them a safe and effective maintenance therapy. DEY's nebulized formoterol will be a valuable addition to the clinician's arsenal."

FDA's approval of Perforomist Inhalation Solution is a significant milestone for the product as well as for DEY's continuing commitment to nebulized respiratory products and patients. The company expects to announce the commercial launch of Perforomist Inhalation Solution in the near future.

About Perforomist (Formoterol Fumarate) Inhalation Solution

The clinical evaluations of Perforomist Inhalation Solution included two clinical trials involving a total of 1,045 patients. In the product's pivotal Phase III trial, 351 patients participated in a 12-week, multi-center, safety and efficacy COPD study. In the study, 123 COPD patients were treated with Perforomist Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil), and 114 COPD patients were treated with placebo. The study's results showed that Perforomist Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV1 AUC 0-12. The safety and efficacy of Perforomist Inhalation Solution observed in this study were comparable to those of Foradil. Additionally, patients treated with Perforomist Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.


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Contact: Harriet Ullman
harriet.ullman@fkhealth.com
617-761-6776
Feinstein Kean Healthcare
11-May-2007


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