FDA Approves OXYTROL® FOR WOMEN, The First Over-the-Counter Treatment For Overactive Bladder In Women

WHITEHOUSE STATION, N.J., Jan. 25, 2013 /PRNewswire/ -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved OXYTROL FOR WOMEN (oxybutynin transdermal system, 3.9 mg/day), the first and only over-the-counter (OTC) treatment for overactive bladder in women. OXYTROL FOR WOMEN addresses an important unmet need for overactive bladder, or OAB, a condition that affects more than 20 million American women. Despite the fact that OAB is a treatable medical condition, more than 80 percent of women with OAB do not seek treatment.

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OAB is characterized by a number of symptoms that can be physically burdensome and emotionally draining, including a strong urge to urinate right away and the need to urinate more often than usual, with or without leakage. The majority of women who suffer develop the condition between the ages of 45 and 60 years old.  According to the National Association for Continence, although OAB is a treatable medical condition, most women do not discuss their symptoms with a doctor and assume that the symptoms are a normal part of aging.  Rather than seek treatment, 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," said Eman Elkadry, M.D., Clinical Instructor 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."

The FDA approval of the prescription to OTC switch was based on data from several well-designed 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, or wrong, for her, and appropriately use OXYTROL FOR WOMEN in an unsupervised setting.  The FDA considers this a partial switch, as OXYTROL will remain available by prescription only for the treatment of OAB in men. The approval follows an FDA Advisory Committee meeting that occurred in November 2012.

"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," said Bridgette P. Heller, Executive Vice President and President, Merck Consumer Care.  "We are proud to bring OXYTROL FOR WOMEN over-the-counter and provide a treatment option that can help women with OAB recognize and treat their symptoms."

Merck anticipates that OXYTROL FOR WOMEN will be available to customers in Fall 2013.

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