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HYDROCORTISONE/DIBUCAINE/MENTHOL COMBO INCLUSION IN OTC ANORECTAL

Executive Summary

HYDROCORTISONE/DIBUCAINE/MENTHOL COMBO INCLUSION IN OTC ANORECTAL monograph or the external analgesic drug monograph was requested by Glaxo in recent petitions to FDA. Glaxo asked that the administrative records for both monographs be reopened to review data on the combination for the purpose of including the combo in the monographs. Because the data relate primarily to the anorectal use of the combination, the company said it would consider withdrawing the petition for the OTC external analgesic monograph if FDA finds it more appropriate to place the combination in the anorectal monograph. Glaxo noted that its Corticaine Gream (0.5% hydrocortisone/0.5% dibucaine/0.31% menthol) has been marketed as an Rx product since 1974 for "the symptomatic relief of certain anorectal, anogenital and dermatological conditions." The company stated that each of the active ingredients has been classified as Category I by FDA and the OTC external analgesics advisory panel. In addition, the firm noted that the combination of dibucaine and menthol at the dosages in Corticaine were placed in Category I in the external analgesics tentative final monograph (TFM). FDA noted in the TFM that "hydrocortisone combinations could be appropriate but that no evidence had been submitted demonstrating that the combination of hydrocortisone with a 'caine' analgesic would meet the criteria of FDA's combination policy," Glaxo stated. The firm pointed out that the hemorrhoidal panel concluded that combinations of OTC ingredients are appropriate for anorectal use and that "combinations of Category I active ingredients from different pharmacologic groups offer a reasonable means for relieving concurrent symptoms." The hydrocortisone/dibucaine/menthol combination provides antipruritic, topical anesthetic and topical analgesic effects, respectively. Glaxo reported that since January 1985 it has been conducting a clinical study to demonstrate efficacy of the combination. The study involves eight test groups, including one placebo group. Glaxo said interim results on 253 patients (of the 400 patients ultimately expected to be tested) demonstrate that Corticaine Cream is "significantly (p < 0.05) more effective than placebo in regard to symptomatic relief and anti-inflammatory effects in patients suffering from acutely symptomatic external hemorrhoids." The company added that "results favoring some combinations of active ingredients over single ingredients are being obtained."
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