FDA approves OTC patch for overactive bladder
The FDA recently approved oxybutynin transdermal (Oxytrol for Women) treatment for overactive bladder (OAB) in women aged 18 years and older. It is the first anticholinergic drug to be made available over the counter (OTC) for treatment of OAB, according to manufacturer Merck.
Oxytrol for Women is a patch that is applied to the skin every 4 days. The patch delivers 3.9 mg of oxybutynin per day.
"Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder," said Shaw Chen, MD, PhD, of the FDA’s Center for Drug Evaluation and Research.
Merck said FDA approval of the prescription-to-OTC switch was based on data from several studies that demonstrated a woman’s ability to correctly recognize OAB symptoms; understand key safety messages on the label; judge whether the product is right or wrong for her; and appropriately use the drug in an unsupervised setting. The FDA considers this a partial switch, as oxybutynin transdermal will remain available only by prescription for the treatment of OAB in men.
Adverse effects reported during clinical studies were mild and included skin irritation where the patch was applied, dry mouth, and constipation, according to Merck. A leaflet with tips to help manage OAB will be provided with the product.
"The approval of Oxytrol for Women as an OTC treatment option is an exciting development for the millions of women who struggle to deal with OAB every day," said Eman Elkadry, MD, of Harvard Medical School and Boston Urogynecology Associates at Mount Auburn Hospital, Cambridge, MA. "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."
Merck said it anticipates that Oxytrol for Women will be available to customers in the fall of 2013.