Merck has received Food and Drug Administration approval for Oxytrol for Women, which the company called the first and only over-the-counter treatment for overactive bladder in women.


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Merck cleared to market OTC Oxytrol for Women

January 28th, 2013

WHITEHOUSE STATION, N.J. – Merck has received Food and Drug Administration approval for Oxytrol for Women, which the company called the first and only over-the-counter treatment for overactive bladder in women.

Merck said Friday that Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) addresses an unmet need for overactive bladder (OAB), a condition that affects more than 20 million American women.

Merck expects Oxytrol for Women to become available to customers in the fall. The patch provides transdermal delivery of oxybutynin, an active ingredient used to treat OAB for more than 30 years. Each patch delivers 3.9 mg of oxybutynin daily for four days and nights­­.

Despite the fact that OAB is a treatable medical condition, more than 80% of women with OAB don't seek treatment, and most women don't discuss their symptoms with a doctor and assume that the symptoms are a normal part of aging, according to Merck. Instead, many women try to manage their condition with coping strategies that include wearing pads and/or dark clothing, mapping out the nearest toilets and avoiding social interactions outside the home.

"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," stated Eman Elkadry, M.D., clinical instructor for Harvard Medical School, Boston Urogynecology Associates, at Mount Auburn Hospital. "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 the 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 if the product is right for her, and properly use Oxytrol for Women in an unsupervised setting. The company reported that the FDA considers this a partial switch, and Oxytrol will remain available by prescription only for the treatment of OAB in men.

"Merck is dedicated to increasing access to safe and effective treatments to help people better manage their health conditions and improve the quality of their lives,” commented Bridgette Heller, executive vice president at Merck and president of Merck Consumer Care. "We are proud to bring Oxtrol for Women over-the-counter and provide a treatment option that can help women with OAB recognize and treat their symptoms."

Merck licensed the exclusive rights to market, distribute and sell Oxytrol as an OTC treatment for OAB from Actavis Inc., formerly known as Watson Pharmaceuticals, Inc.

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