Topical Gel for Overactive Bladder Approved

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Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, has received FDA approval.

Marketed by Watson Pharmaceuticals, Inc., of Corona, Calif., Gelnique has been shown in a 12-week phase 3 trial to provide ease, efficacy, and excellent tolerability and will give OAB patients an effective and novel alternative to current oral treatment options. Because the drug's active ingredient is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin.

This lowers the incidence of side effects, such as dry mouth and constipation. “Based on the results of a clinical trial and considering its unique delivery system, we expect that GELNIQUE will be used as a first-line therapy for the treatment of OAB,” said Paul Bisaro, chief executive officer of Watson. The company expects to make Gelnique available to patients in the second quarter of this year.

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