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Executive Summary

ORTHO MICATIN ATHLETE's FOOT PREVENTION STUDIES "NOT SUFFICIENT" to support a claim of prophylaxis, FDA's Division of OTC Drug Evaluation said in an Aug. 22 letter to Ortho Pharmaceutical. FDA said that Ortho needs to submit two adequate and well-controlled studies supporting the prevention claim before OTC miconazole nitrate 2% can be considered for inclusion in the final monograph of OTC topical antifungal drug products. Ortho submitted two clinical studies to FDA in April 1990 to support its request that miconazole be included in FDA's December 1989 tentative final monograph for antifungals as a preventative for athlete's foot. OTC miconazole is listed as Category I in the TFM only for the treatment of athlete's foot ("The Pink Sheet" Dec. 18, 1989, p. 17). FDA invited Ortho to discuss a protocol for a clinical trial, but suggested the company first submit a protocol addressing some of the Agency's reservations. Ortho has been trying to get miconazole designated a Category I OTC antifungal for the prophylaxis claim since 1985. One trial, entitled "Clinical Prophylaxis Study of Miconazole Nitrate 2% (powder) in Comparison to the Vehicle (100% Talcum Powder) and to No Preventative Medication in the Treatment of Tinea Pedis," reported the results from 27 participants in a double-blind, multicenter study, each of whom were randomized to one of the three treatment conditions. All patients had participated in an earlier clinical study of the effectiveness of three different athlete's foot therapies and had achieved a therapeutic cure. The participants were followed for 12 weeks. FDA cited "a number of defects" in its rejection of the study as insufficient, including: the lack of a sufficient number of subjects for a statistically significant evaluation of effectiveness; the identification of the causative organisms of athlete's foot in "only a few" of the patients, although different organisms are variously difficult to eradicate; and the failure of Ortho to provide the agency with a key to determine to which treatment-arm various patients were assigned. FDA further noted that this study was submitted in May 1984 as a supplement to an approved NDA and that the agency told Ortho the studies were inadequate in a July 1986 letter. The study had been resubmitted in February 1985 as part of citizen petition asking for the reopening of the administrative record to consider miconazole nitrate as a Category I preventative for athlete's foot. Ortho also submitted a 1978 study from the British Journal of Clinical Practice entitled "The Treatment of Chronic Athlete's Foot: A Possible Role for Prophylaxis"; FDA, however, said the study was "primarily designed as a short-term treatment study . . . and not as a prophylaxis study," and is therefore insufficient. All patients entering the study, FDA said, had clinical symptoms of athlete's foot.

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