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Executive Summary

JANSSEN's NIZORAL FOR RECALCITRANT DERMATOPHYTE INFECTIONS, in patients unresponsive or intolerant to griseofulvin therapy, was recommended for approval by FDA's Dermatologic Drugs Advisory Cmte. at its Nov. 5 meeting. The cmte. unanimously agreed clinical studies provide sufficient evidence of Nizoral's (ketoconazole) efficacy in "suppressing recalcitrant dermatophyte infections." Nizoral is currently indicated for the treatment of systemic fungal infections, including candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. The recalcitrant dermatophyte claim was included in the original Nizoral NDA, which was filed in July 1980. FDA approved the sole claim for systemic fungal infections in June 1981. Janssen also filed an NDA in July 1983 for a topical ketoconazole formulation for use in superficial fungal infections, such as tinea pedis, tinea versicolor, tinea corporis, and tinea cruris. Commenting on adverse reaction reports for the drug, Janssen representatives noted that the company recently revised Nizoral labeling to point out that "in rare cases anaphylaxis has been reported after the first dose." Janssen Medical Director Gil Huebner, MD, said there have been four reports of anaphylactic reactions, three of which occurred in patients within 1-20 hours after they received one 200 mg Nizoral tablet, and one incident which occurred one month after ketoconazole therapy. He said there have been 11 other cases of anaphylaxis reported in Europe. Cmte. member Wilma Bergfeld, MD, Cleveland Clinic, referring to the cmte.'s previous experience with methotrexate and Accutane, said all concerns with Nizoral can be handled in the labeling. The cmte. agreed with her recommendation that labeling include black italics and black boxes noting the drug's association with hepatotoxicity and anaphylactic reactions. Janssen revised the labeling in June 1983 to include a boxed warning at the head of the insert on the drug's association with hepatocellular toxicity. The cmte. also suggested that the company provide patient information sheets with Nizoral, and that the fungus species be identified if the drug is used more than three months.

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