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news.The FDA has notified Sepracor that the company's new drug application for arformoterol tartrate inhalation solution, a drug candidate for chronic obstructive pulmonary disease, has been filed under formal review.
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Arformoterol tartrate is a long-acting beta-agonist formulation for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the US according to the US National Center for Health Statistics.
Arformoterol, a single isomer of formoterol, is the first long-acting bronchodilator to be developed in an inhalation solution for use with a nebulizer. Other long-acting bronchodilators currently available are formulated in dry-powder inhalers or metered-dose inhalers.
Sepracor has completed more than 100 preclinical and 16 clinical studies of arformoterol involving more than 2,000 patients. Among the clinical studies conducted were two 12-week pivotal studies, each with more than 700 patients, as well as a large-scale, 12-month safety study.
In phase III studies, patients treated with arformoterol demonstrated a statistically significant improvement in FEV1, which is a test of lung function, versus those administered placebo.
The FDA is expected to review and act upon the new drug application (NDA) submission by October 12, 2006.