Executive Summary

HYDROCORTISONE 1% RECTAL SUPPOSITORIES REQUIRE CLINICALS to demonstrate efficacy of the product, the agency told Parke-Davis in denying its ANDA suitability petition. FDA stated that suppository products were not included in previous DESI notices that ruled effective 0.5% topical hydrocortisone and hydrocortisone acetate products. "A suppository preparation involves not only a different dosage form but also a different route of administration from the preparations described in these notices," the agency explained. FDA continued: "A suppository is inserted beyond the sphincter muscle, so that the amount of drug available in the anogenital area to treat dermatoses is unclear. Thus, the effectiveness of a suppository preparation on dermatoses is not apparent from a finding of effectiveness of a topically applied ointment, cream, lotion or spray and investigations to demonstrate effectiveness are necessary." Parke-Davis cited four products as potential reference listed drugs: Reid-Rowell's Proctocort 1% topical rectal cream and Cortenema 100 mg/60 ml hydrocortisone rectal enema; and Reed & Carnrick's Proctofoam HC (hydrocortisone acetate/pramoxine HCl) 1% rectal foam and Cortifoam 10% rectal foam aerosol. FDA asserted that the safety and efficacy data for any one of the four products could not be extended to hydrocortisone suppositories. The agency noted that Proctocort and Proctofoam HC have a different dosage form and route of administration than hydrocortisone suppositories. Furthermore, "Proctofoam HC is a combination product comprised of two active ingredients, not one as in the proposed product," FDA said. The active ingredient in Proctocort also differs from that in Parke-Davis' proposed product. The agency stated that Cortifoam and Cortenema are approved for different indications than that of Parke-Davis' proposed hydrocortisone product. Parke-Davis is seeking an indication for "relief of the inflammatory manifestations of corticosteroid-responsive dermatoses of the anogenital area." Cortifoam and Cortenema are indicated as adjunctive therapy in the treatment of ulcerative proctitis. In addition, FDA said Cortifoam contains hydrocortisone at a 10-fold greater concentration than the Parke-Davis product.