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Clinical trial data for Perforomist Inhalation Solution presented at International ATS Conference

Napa, CA (May 21, 2007) -- Data presented at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist (formoterol fumarate) Inhalation Solution, delivered by nebulization, is an effective and well-tolerated new treatment option for patients suffering from emphysema or chronic bronchitis, otherwise known as Chronic Obstructive Pulmonary Disease (COPD). "Nebulized Formoterol is an Effective Bronchodilator and Improves the Quality of Life for COPD Patients" presented results of the Phase III pivotal clinical study, a 12-week randomized, double-blind, double-dummy, placebo- and active-controlled trial. The trial found that Perforomist Inhalation Solution, a twice-daily, long-acting beta2-agonist (LABA):

  • provided rapid bronchodilation that lasted a full 12 hours,
  • enabled patients to use less rescue medication,
  • maintained improvements in lung function with no evidence of tolerance (tachyphylaxis) over the 12-week period, and
  • improved the lung function and quality of life of patients compared to placebo.

No significant difference in efficacy was observed over 12 weeks of treatment between Perforomist Inhalation Solution and the active comparator, dry powder Foradil.

A separate presentation given at ATS detailed the safety results of the same trial. "Safety Profile of Formoterol Fumarate Delivered by Nebulization to COPD Patients" found that Perforomist Inhalation Solution was well tolerated, had a safety profile similar to that of Foradil, and resulted in fewer COPD exacerbations than was seen with placebo. Taken together, the data from these two presentations demonstrate that Perforomist Inhalation Solution will provide a new, safe and effective therapeutic option for long-term maintenance treatment of COPD.

Nicholas J. Gross, MD, PhD, an expert on lung diseases, particularly COPD, was the Principal Investigator for the Phase III pivo
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Contact: Harriet Ullman
harriet.ullman@fkhealth.com
617-577-8110
Feinstein Kean Healthcare
21-May-2007


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