Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, Inc. today announced the filing of 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 for Anturol represents a significant accomplishment for the Company in 2010. The dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement”

The NDA submission was supported by a Phase 3 clinical trial, which demonstrated a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily). The trial was conducted under a Special Protocol Assessment (SPA) with the FDA. In addition, an Open Label Extension study, evaluating long-term safety has been successfully completed.

"The NDA submission for Anturol represents a significant accomplishment for the Company in 2010. The dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement," said Paul K. Wotton Ph.D., President and Chief Executive Officer.

Anturol Phase 3 Trial

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 trial was a double blind, randomized, parallel placebo-controlled multi-center study that evaluated the efficacy and safety of Anturol in 600 subjects with overactive bladder. The primary objective of the study was to demonstrate that daily treatment of 56mg or 84mg dose of oxybutynin applied in the ATD^TM Gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms. 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,>

Secondary end points included changes from baseline in average daily urinary frequency, void volume, patient perceptions, as well as safety and tolerability including skin irritation. Although not the basis for approval, the 84 mg dose provided highly statistically significant results for the secondary end points of urinary frequency and volume while the 56 mg dose did not reach statistical significance. Additionally, Anturol which uses the proprietary ATD Gel technology was well tolerated in the study. No serious adverse events related to the treatment were reported. Anticholinergic side effects such as dry mouth and constipation were low and no CNS side effects were seen compared to placebo. Treatment-related adverse events that resulted in study discontinuation during the double-blind period were low and similar for both the treatment and placebo groups.