St. Louis (MD Consult) – January 25, 2013 – The U.S. Food and Drug Administration (FDA) and Merck announced that female Oxytrol (oxybutynin transdermal delivery system, 3.9 mg/d) has become the first drug approved for the treatment of overactive bladder disorder in women aged ≥18 years ( Oxytrol (Oxybutynin transdermal delivery system, 3.9 mg/d) has become the first over-the-counter (OTC) drug approved for the treatment of overactive bladder ( OAB) in women aged ≥18 years. For men, Oxytrol will remain available as a prescription drug for the treatment of OAB. Oxybutynin is an anticholinergic drug.
The safety and efficacy of Oxytrol for women as an OTC drug has been confirmed in nine studies that included a total of more than 5,000 patients. Overall, the results of these studies indicate that consumers are able to understand the information on the drug label and are able to properly select the right product for them and use it appropriately.
Adverse reactions reported in the clinical studies were mild and included skin irritation, dry mouth and constipation at the site of patch application.
Merck expects to begin marketing Oxytrol for women in the fall of 2013.