Antares meets with FDA following phase 2 trial of Anturol for overactive bladder

By Lisa Kerner

Charlotte, N.C., June 26 - Antares Pharma, Inc. said it met with the Food and Drug Administration to discuss its positive phase 2 clinical study results for Anturol, its clear, odorless, once-a-day oxybutynin gel product for the treatment of overactive bladder (OAB).

"We are pleased with the outcome of the end of phase 2 meeting with the FDA and we believe our final protocol will provide Antares with an efficient pathway for approval of Anturol," managing director Dario N. Carrara said in a company news release.

Antares plans to begin a phase 3 clinical program in patients with urge and mixed urinary incontinence once protocol details are finalized. The trial is expected to be a randomized, double-blinded, placebo-controlled multi-center study evaluating the effect of 12 weeks of Anturol treatment in patients with OAB.

OAB affects about 17 million Americans and is one of the fastest growing segments of the urology market, according to the release.

Based in Exton, Pa., Antares develops patented drug delivery systems.

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