Antares Pharma, Inc. announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Anturol Gel in patients with overactive bladder (OAB).
The NDA submission, subject to acceptance by FDA, was supported by a Phase 3 trial conducted under a Special Protocol Assessment (SPA) with FDA. The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033 respectively).
Anturol offers many potential advantages over currently marketed products for the treatment of OAB. As Anturol is dispensed in a pump and applied directly to the skin once daily, potential advantages include a more reproducible and convenient dosing formulation, the ability to titrate the dosage, and potential for fewer side effects or adverse events.
Date: December 22, 2010
Source: Antares Pharma, Inc.
Filed Under: Drug Discovery
