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Merck’s Oxytrol Could Be OTC Trailblazer For Chronic Conditions

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck’s Oxytrol for Women has the opportunity to “create the market” for OTC overactive bladder drugs, as well as encourage other switches for chronic, progressive conditions, marketing consultant Joe McGovern says. The transdermal patch product is slated to launch in September.

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Merck’s proposed Rx-to-OTC switch of Oxytrol for Women is about identifying symptoms of overactive bladder, not diagnosing the condition, says Eric Brass, former chair of FDA’s Nonprescription Drugs Advisory Committee. Several NDAC members Nov. 9 insisted OAB should be diagnosed before treatment.

NDAC Puts Hitch In Oxytrol Switch With Negative Self-Selection Vote

In a 6-5 vote, FDA’s Nonprescription Drugs Advisory Committee said Merck did not show that consumers can appropriately self-select to use Oxytrol for Women in an OTC setting. The company expects to hear from FDA on its Rx-to-OTC switch application by the end of January.

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