February 13, 2013
OTC Patch for Overactive Bladder in Women Available in Fall

Whitehouse Station, NJ—Coming soon is a new option pharmacists can recommend for women with urinary incontinence, urinary urgency, or frequent urination.

Oxytrol for Women recently was approved by the FDA for OTC purchase, the first such treatment for overactive bladder in women 18 years old and older.

Women make up the majority of the 33 million Americans who suffer from overactive bladder symptoms, according to the FDA. A prescription still will be required for Oxytrol treatment of overactive bladder in men.

Delivered by a patch that is applied to the skin every 4 days, Oxytrol for Women delivers 3.9 mg of oxybutynin per day. Oxybutynin is an anticholinergic that helps relax the bladder muscle.

“Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder,” said Shaw Chen, MD, PhD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “Women should make sure to follow the Drug Facts label and consult their doctor if their condition does not improve.”

Nine studies involving more than 5,000 participants were used to establish the safety and effectiveness for Oxytrol for Women as an OTC product. From that data, the FDA determined that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately.

Only mild side effects were reported during clinical studies, including skin irritation where the patch was applied, dry mouth and constipation. Merck, which sought approval of the drug, will be providing with the product a leaflet with tips to help manage overactive bladder.

In a press release issued by Merck, Eman Elkadry, MD, a clinical instructor at Harvard Medical School in Boston, noted, “This effective, over-the-counter treatment offers women an option to independently manage their condition and achieve a newfound sense of control. The approval also provides recognition that this is a real medical disorder that can be addressed.”

A Merck press release said the OTC product should be available by the fall.

U.S. Pharmacist Social Connect