FDA approves topical gel to treat overactive bladder

February 12, 2009

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

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

The gel was developed to provide OAB patients with an alternative to currently available oral treatment options. Because the drug is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin. The goal is to reduce side effects, including dry mouth and constipation, according to the drug’s manufacturer, Watson Pharmaceuticals.

The drug’s approval was based on a phase III randomized, double-blind, placebo-controlled, parallel group trial that evaluated 789 patients with signs and symptoms of OAB. During the 12-week trial, a 1-gram, once-daily dose of oxybutynin chloride 10% gel was found to be more effective than placebo at relieving OAB symptoms, including reducing incontinence episodes and urinary frequency, and increasing urine void volume.