POVIDONE-IODINE 10% ANTIFUNGAL IS CATEGORY I

Executive Summary

POVIDONE-IODINE 10% ANTIFUNGAL IS CATEGORY I for the treatment of athlete's foot, jock itch, and ringworm, FDA told Purdue Frederick in a recent feedback letter. FDA OTC Drug Evaluation Div. Director William Gilbertson, PharmD, told the company that a study submitted in June 1982, "along with the information previously reviewed by the panel, provides adequate evidence of the safety and effectivness of 10% povidone-iodone" in the treatment of fungal infections. Gilbertson said the OTC drug division is therefore recommending the ingredient to Category I in the OTC topical antifungal monograph. Commenting on Purdue Frederick's study of 40 patients with tinea pedis, Gilbertson said the results "clearly indicate the effectiveness of the povidone-iodone solution in the management of dermatophytosis." He stated that after four weeks the solution "cleared 68.4% of the patients while the solution without povidone-iodine cleared 30%. These cure rates were sustained to four weeks post therapy and the difference is statistically significant (p<0.05)." FDA commented that a "significant number of cases" in Purdue Frederick's study were culture positive for T. rubrum, "which is considered to be the 'base' organism for evaluation of the effectiveness of a drug used for athlete's foot." Gilberston said the agency "agrees with the panel that a drug shown to be effective in the treatment of athlete's foot will also be effective in jock itch and ringworm because the infecting organisms of these conditions are representative of the same group as the organisms causing athlete's foot and have been shown to be susceptible to the same antifungal drugs."