The FDA has approved Antares’ topical oxybutynin gel 3% for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.

The gel is delivered through a metered-dose pump and applied once daily to the thigh, abdomen, upper arm or shoulder, an 84 mg (approx. 3 mL) dose delivers a consistent dose of oxybutynin through the skin over a 24-hour period.

Approval is based on a 12-week, placebo controlled phase III trial evaluating an 84 mg and a 56 mg dose application of oxybutynin gel vs. placebo (the FDA approved 84 mg dose). Patients treated with 84 mg oxybutynin gel daily achieved steady state drug concentrations within three days and experienced a reduction in OAB symptoms vs. placebo, including the number of urinary incontinence episodes per week. The most frequently reported treatment-related adverse events (>3%) were dry mouth (12.1% vs. 5% placebo), application site erythema (3.7% vs. 1.0% in placebo) and application site rash (3.3% vs. 0.5% in placebo).