FDA green-light's Antares' overactive bladder gel; Watson to sell it

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Antares Pharma's ($AIS) new topical gel to treat overactive bladder will hit the U.S. commercial market in the spring. FDA approval for the drug variation was announced Dec. 8. Fellow New Jersey company Watson Pharmaceuticals ($WPI) will sell it under an exclusive licensing agreement.

Overactive bladder is a condition in which patients suddenly need to urinate and do so frequently. The condition can be uncomfortable, often lead to urge urinary incontinence and affects as many as 33 million adults in the U.S. alone.

Antares' oxybutynin gel 3% delivers a steady dose of the drug transdermally over 24 hours. It is being marketed as an improvement over orally administered oxybutynin because the liver metabolizes it differently when absorbed through the skin, leading to milder side effects such as dry mouth and constipation. Oxybutynin is an antispasmodic, antimuscarinic agent. The FDA approved a dose of 84 mg of the translucent hydroalcoholic gel to be applied once a day, through a metered-dose pump, to the thigh, abdomen, upper arm or shoulder.

Antares made it to the regulatory finish line based on a 12-week, multicenter placebo controlled Phase III clinical trial. The study demonstrated that the gel achieved steady drug concentrations within three days, and that patients saw a "statistically significant" decline in overactive bladder symptoms versus placebo. (Patients were also randomized to a 56 mg dose during the trial.) Interestingly, the gel worked properly even when patients showered an hour after their dose, or applied sunscreen either a half-hour before or after their dose, the company said.

- here's the release

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