Watson Pharmaceuticals, Inc. (WPI) and Antares Pharma, Inc. (AIS) announced that the U.S. Food and Drug Administration, or FDA, has approved Antares' topical oxybutynin gel 3% product for treating overactive bladder, or OAB, with symptoms of urge urinary incontinence, urgency and frequency. Under an exclusive licensing agreement, Watson anticipates launching the product in 2012.
Antares' oxybutynin product is a clear, odorless topical gel available in a convenient, metered-dose pump that has demonstrated to be an effective and safe treatment for OAB. The active ingredient is delivered transdermally and hence, it is not metabolized by the liver in the same way as orally administered oxybutynin, which results in a low level of side effects, such as dry mouth and constipation.
The approval of Antares' oxybutynin gel 3% is based on a 12-week, multi-center placebo controlled Phase 3 clinical study conducted by Antares. The product was well tolerated in the study.
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