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Clinical trial data: Safety/efficacy of concomitant formoterol fumarate/tiotropium treating COPD

Napa, CA (October 24, 2007) Data presented today at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP), demonstrate concomitant use of nebulized formoterol fumarate and tiotropium provided improved bronchodilation over tiotropium monotherapy and was well-tolerated in this clinical study. The only commercially available version of nebulized formoterol fumarate is Perforomist Inhalation Solution, which is indicated for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Formoterol fumarate is a rapid and long-acting beta2-agonist (LABA) that has been previously available in the U.S. in a dry powder formulation and has twenty years of worldwide experience. Perforomist Inhalation Solution is the first and only FDA-approved nebulized form of this molecule. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

Results presented were from Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol and Tiotropium in COPD, a randomized, placebo-controlled Phase IIIb trial. The trial demonstrated that concomitant therapy with twice-daily nebulized formoterol fumarate (FFIS) and once-daily tiotropium provided patients with statistically significant and clinically relevant improvements in bronchodilation over treatment with tiotropium alone. In this six-week study, patients receiving concomitant therapy with nebulized FFIS and tiotropium experienced fewer adverse events or COPD exacerbations than patients receiving placebo or tiotropium monotherapy.

According to Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles and the lead clinical investigator, For the patients in this study, adjunctive use of nebulized formoterol fumarate and tiotropium showed statistically significant improvements in lung function by improving bronchodilation over use of tiotropium alone. For physicians, Perforomist Inhalation Solution and commonly prescribed long-acting anticholinergics such as tiotropium offers a new and valuable treatment option for COPD patients with moderate to severe manifestations of the disease.

Christy Taylor, Chief Operating Officer at Dey, L.P., commented, At DEY, we specialize in developing effective new treatments for serious and complex respiratory diseases, and it is gratifying that the newest addition to our franchise, Perforomist Inhalation Solution, offers physicians additional prescribing flexibility. For over a decade, Dey, L.P. has been the U.S. leader in sales of nebulized respiratory medication. We thank Dr. Tashkin and the other members of the research team for their assessment of how Perforomist Inhalation Solution may be used concomitantly with tiotropium for improved clinical effect for COPD patients.

For those attending CHEST 2007, the presentation is available as follows:

Poster viewing: Session ID 902 - COPD Treatment II
Wednesday, October 24, 2007, 12:30 2:00 PM
Convention Center, Exhibit Hall, McCormick Place, Lakeside Center, Chicago.

Poster # 251: Safety and Efficacy of Concomitant Treatment with Nebulized Formoterol and Tiotropium in COPD


Contact: Amy Techtmann
Feinstein Kean Healthcare

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