Gelnique gel approved for OAB

The FDA has approved Watson's Gelnique (oxybutynin chloride) gel 10% for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. This approval is based on data from a phase 3, double-blind, placebo-controlled trial of 789 patients that showed Gelnique gel relieved OAB symptoms.  The study concluded in a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume when compared to placebo. Due to the transdermal application, Gelnique gel reported of lower levels of side effects such as dry mouth and constipation.

Gelnique gel is expected to be available in the second quarter of 2009.

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