Merck & Co. Inc. announced 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% of women with OAB do not seek treatment. 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 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.