FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

Antares PharmaApr 8 2011

Antares Pharma, Inc. (NYSE Amex: AIS) today announced the New Drug Application (NDA) for Anturol^® Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel incorporating Antares' ATD Gel technology.

“The FDA's acceptance for filing of the NDA for Anturol, Antares Pharma's first NDA, is another notable achievement for the Company resulting from the dedicated efforts of the entire Antares team. This is an important accomplishment in the continued execution of our product focused strategy”

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.

"The FDA's acceptance of the NDA filing is an important milestone in the review process to secure approval from the FDA for commercial distribution of Anturol. We look forward to working with the FDA in their ongoing review of Anturol," said Kaushik J. Dave R.Ph., Ph. D., MBA, Senior VP Product Development of Antares Pharma.

The Anturol NDA submission is supported by data from a Phase 3 randomized, double-blind, placebo-controlled clinical trial involving 600 patients with OAB. In the 12-week study, patients treated with Anturol 56 mg daily or 84 mg daily experienced a significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day. Anturol was well tolerated in the study with no reported serious treatment-related adverse events. Anticholinergic side effects such as dry mouth and constipation were low and no increase in CNS side effects was seen compared to placebo. The study was conducted under a Special Protocol Assessment (SPA) by the FDA.

"The FDA's acceptance for filing of the NDA for Anturol, Antares Pharma's first NDA, is another notable achievement for the Company resulting from the dedicated efforts of the entire Antares team. This is an important accomplishment in the continued execution of our product focused strategy," said Paul K. Wotton Ph.D., President and Chief Executive Officer.