WHITEHOUSE STATION, N.J., Nov. 9, 2012 - Today, Merck (NYSE: MRK), known as MSD outside the United States and Canada, confirmed that the U.S. Food and Drug Administration’s (FDA) Nonprescription Drug Advisory Committee proposed that the FDA consider labeling modifications as part of their review of OXYTROL (oxybutynin transdermal system) as an over-the-counter (OTC) treatment for overactive bladder (OAB) in women. The proposed brand name for the OTC product is OXYTROL FOR WOMEN. The panel members generally agreed that OXYTROL has demonstrated a favorable safety profile since it was first approved by the FDA as a prescription treatment in 2003. The FDA generally follows advisory committee recommendations, although it is not bound to do so.
Overactive bladder is a physically and emotionally draining condition affecting over 20 million women in theU.S. Rather than seek treatment, the majority of women choose to self-manage their condition with coping strategies that include pads, dark clothing, mapping out the nearest toilets, and avoiding social interactions outside the home.
“Access to an effective, over-the-counter treatment could significantly improve how women manage this condition, and help to treat the symptoms that current coping strategies cannot,” said Bridgette P. Heller, Executive Vice President and President, Merck Consumer Care. “We will continue to work closely with the FDA to address any questions the FDA might have in order to bring OXYTROL FOR WOMEN over-the-counter.”
OXYTROL is currently the only transdermal system (patch) available to treat OAB with a prescription. OXYTROL has been available by prescription since 2003. The active ingredient, oxybutynin, has been used to treat OAB for more than 30 years.
Merck licensed the exclusive rights to market, distribute and sell OXYTROL as a potential OTC treatment for OAB from Watson Pharma Inc. (NYSE: WPI).
Important Safety Information
The most commonly reported adverse events were application site reactions, dry mouth, constipation, diarrhea, dysuria, and abnormal vision. OXYTROL is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. OXYTROL is also contraindicated in patients who have demonstrated hypersensitivity to oxybutynin or other components of the product. OXYTROL should be administered with caution in the following patients: those with hepatic or renal impairment; clinically significant bladder outflow obstruction; gastrointestinal obstructive disorders because of the risk of gastric retention; patients with gastroesophageal reflux. Please see Prescribing Information.
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