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FDA panel expresses concern over OTC OAB patch

Merck has confirmed that the FDA Nonprescription Drug Advisory Committee proposed that the FDA consider labeling modifications as part of its review of oxybutynin transdermal system (Oxytrol) as an over-the-counter treatment for overactive bladder in women.

The panel members generally agreed that the system has demonstrated a favorable safety profile since it was first approved by the FDA as a prescription treatment in 2003. But the panel voted against making the system available over the counter (proposed brand name, OXYTROL FOR WOMEN), citing concerns about using the product without a physician’s oversight. The FDA generally follows advisory committee recommendations, although it is not bound to do so.

"I don't think that we have shown that patients can appropriately self-select," said committee member Philip M. Hanno, MD, MPH, of the University of Pennsylvania in Philadelphia.

"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, of 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."

Merck licensed the exclusive rights to market, distribute, and sell OXYTROL as a potential OTC treatment for OAB from Watson Pharma Inc. According to media reports, the FDA is scheduled to make a decision on the drug by the end of January.

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