First and Only Topical Gel for Overactive Bladder Cleared

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Watson Pharmaceuticals, Corona, Calif., has received approval for Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB).

The quick-drying, clear, colorless, and fragrance-free hydroalcoholic gel is applied once daily to the thigh, abdomen, upper arm, or shoulder to relieve OAB symptoms, including urge urinary incontinence, urgency, and frequency.

Gelnique is delivered transdermally so it avoids first-pass metabolism, thus decreasing formation of the N-desethyloxybutyin metabolite. This reduces adverse effects, such as dry mouth and constipation. In clinical trials, these adverse effects occurred in 6.9% and 1.3% of subjects. Application-site reactions were seen in 5.4% of patients.

In a 12-week phase 3 trial, 1 g of Gelnique applied once daily was superior to placebo at relieving OAB symptoms, including a reduction in incontinence episodes and urinary frequency and an increase in urine void volume.

Additional studies showed that showering one hour later or applying sunscreen lotion 30 minutes before or after using Gelnique did not significantly alter its absorption.

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