EXTON, Pa.--(BUSINESS WIRE)--June 26, 2006--Antares Pharma, Inc. (Amex:AIS - News) announced that an end of Phase II meeting was held with the U.S. Food and Drug Administration (FDA), based on the positive Phase II clinical study results for Anturol(TM), its oxybutynin gel product for the treatment of overactive bladder (OAB). Antares 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 patients. It is expected to support an optimized regulatory strategy with submission of an NDA anticipated before the end of 2007.
