Sepracor seeks FDA approval for respiratory drug

Arformoterol 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 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 a test of lung function, versus those patients administered placebo.

“Many patients who are affected by COPD, which encompasses chronic bronchitis and emphysema, may prefer the inhalation solution delivery method since it can be easier to administer than other drug delivery systems,” said Dr Mark Corrigan, executive vice president of R&D at Sepracor.