Antares’ Overactive Bladder Gel Faces Phase III
This article was originally published in The Pink Sheet Daily
Executive Summary
Antares expects to submit an NDA for its oxybutynin gel product Anturol for overactive bladder by the end of 2007, the firm said June 26
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Antares expects to submit an NDA for its oxybutynin gel product Anturol for overactive bladder by the end of 2007, the firm said June 26. The firm completed a successful Phase II trial in February for the transdermal gel product. The 48-patient study, in which each patient received three different doses over 20 days, found a "reduced adverse event profile in comparison to those reported in both oral and adhesive patch formulations," the firm said. A forthcoming Phase III trial will likely be a randomized, double-blind, placebo-controlled study evaluating the effect of 12 weeks of Anturol treatment. Antares said it is continuing development of Anturol "as we explore opportunities with potential marketing partners." Anturol is a clear, odorless gel that is applied to the abdomen once a day. |