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NSAID Rx-TO-OTC SWITCH CRITERIA WILL BE DISCUSSED IN FEBRUARY

Executive Summary

NSAID Rx-TO-OTC SWITCH CRITERIA WILL BE DISCUSSED IN FEBRUARY by FDA's Arthritis Drugs Advisory Committee, FDA Pilot Drug Evaluation Staff Acting Director John Harter, MD, told the Nonprescription Drug Manufacturers Association's Research & Scientific Development Conference Nov. 17. The committee is scheduled to meet on Feb. 22. Noting that there are a number of companies evaluating nonsteroidal anti-inflammatory drug (NSAID) OTC switch candidates, Harter said that the committee should be helpful in deciding which NSAIDs are appropriate for such switches. The committee is expected to consider the characteristics that would make a prescription NSAID suitable for OTC marketing and the type of studies that would be necessary to support a switch. NSAID Rx-to-OTC switch issues are a familiar topic to the arthritis drug panel. In August 1984, the committee concluded that ibuprofen was a suitable candidate for OTC marketing. Merck has several NSAIDs that could be targeted for the OTC market. Merck Chairman Roy Vagelos has stated publicly that its NSAID Dolobid (diflunisal) is a logical switch candidate. Merck also has the NSAIDs Clinoril (sulindac) and Indocin (indomethacin). Some trade sources believe that Merck may be actively developing an OTC version of Clinoril; the product is slated to come off patent in 1990 and an OTC switch would be an appealing option for expanding sales. Indocin is currently facing heavy generic competition. Syntex is working with Procter & Gamble on an Rx-to-OTC switch of the NSAID Naprosyn (naproxen). The switch is part of Syntex' strategy in preparing for Naprosyn's patent expiration in 1993. Harter also discussed his review of the computer-assisted NDA for Whitehall's CoAdvil, an OTC combination of ibuprofen 200 mg/pseudoephedrine 30 mg, which was recently approved. He noted that another computer-assisted OTC application was submitted to the agency, but it had to be substantially revised. That submission, for an unidentified product, was done to support upgrading of the product from Category III to Category I. In support of the CoAdvil NDA, Whitehall was required to do a large Phase III trial involving 737 patients to see whether patients followed label directions. "There were probably not 50 people in that 737 that took the drug identically over the 10 days of the trial. There were almost 700 patterns," Harter said, noting that he did not expect such variation. In light of the results, he told the audience, sponsors are "going to need to develop your own expertise in OTC conditions; it's not out there right now." In general comments on computer-assisted NDAs, Harter said: "I think that they make our job easier and make your job easier." He added that "of the nine that I've been involved with, there's no doubt in my mind that it saves time. It may not cut the review time, but it cuts the approval time." For companies that do not have experience with these NDAs, the FDAer recommends that sponsors "go to a third-party person who's had some experience and let them do the first one for you."

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