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2/28/2003

Transdermal System Approved for Bladder Control

Cheryl A. Thompson

Oxytrol, an oxybutynin-based transdermal delivery system for treating overactive bladder, was approved for marketing Wednesday by the Food and Drug Administration. Watson Pharmaceuticals Inc. said the product will be available in pharmacies toward the end of May.

According to the company, the product delivers 3.9 mg/day of oxybutynin through a patient's skin and into the bloodstream for up to four days, thus allowing for twice-weekly application.

A company official said the frequencies of dry mouth and constipation during the clinical studies of the oxybutynin transdermal system did not differ significantly from the rates for placebo. The most common adverse event, which occurred in less than 17 percent of patients during the studies, was pruritus at the site on the abdomen where the patch was applied. Labeling for the product, the official said, notes that the patch may be applied to the abdomen, hip, or buttock.

The company said that the oxybutynin transdermal system should not used by patients with urinary or gastric retention, uncontrolled narrow-angle glaucoma, or hypersensitivity to the drug.