Sepracor submits NDA to treat pulmonary disease

Sepracor Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for arformoterol tartrate inhalation solution, a formulation for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).

Company officials say arformoterol is the first long-acting bronchodilator to be developed in an inhalation solution for use with a nebulizer, which is a machine that converts liquid medication into a fine mist that is inhaled through a mask.

Other long-acting bronchodilators currently available are formulated in dry-powder inhalers or metered-dose inhalers.

Under the Prescription Drug User Fee Act, the FDA has 60 days after submission to review an NDA in order to determine if the application may be filed. The filing of an application means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.

Approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is under-diagnosed, according to the National Heart, Lung, and Blood Institute (NHLBI).

Sepracor stock was trading at mid-morning for $53.41, down 31 cents from its close yesterday.

Comments

If you are commenting using a Facebook account, your profile information may be displayed with your comment depending on your privacy settings. By leaving the 'Post to Facebook' box selected, your comment will be published to your Facebook profile in addition to the space below.