Having obtained positive results with Anturol, an oxybutynin gel product, in a phase II clinical study, Antares now plans to initiate a phase III clinical program in patients with urge and mixed urinary incontinence, pending finalization of protocol-specific details.
The phase III protocol is currently defined as a randomized, double-blinded, placebo-controlled multi-center study evaluating the effect of 12 weeks of Anturol treatment in overactive bladder (OAB) patients. It is expected to support an optimized regulatory strategy with submission of a new drug application (NDA) anticipated before the end of 2007.
“We are pleased with the outcome of the end of phase II meeting with the FDA and we believe our final protocol will provide Antares with an efficient pathway for approval of Anturol,” commented Dr Dario Carrara, managing director of Antares' pharmaceutical operations in Basel, Switzerland.
“We are pleased to be able to continue the development program for Anturol as we explore opportunities with potential marketing partners,” added Jack Stover, Antares' president and CEO. “Anturol is an important new formulation and method of treatment for OAB which we believe will be well positioned to compete in the growing urinary incontinence market.”