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Executive Summary

WHITEHALL DEVELOPING ADDITIONAL DATA ON LIVE YEAST CELL DERIVATIVE as a wound-healing agent, the company said in a June 25 letter to FDA. The agency told the American Home Products subsidiary in March that data from two studies of LYCD were inadequate to demonstrate effectiveness for another use ("The Pink Sheet" March 30, T&G-1). LYCD is the principal ingredient in Whitehall's Preparation H cream/ointment/suppository products for OTC relief of hemorrhoidal symptoms. LYCD is also in the formula for AHP subsidiary Wyeth-Ayerst's Wyanoids OTC hemorrhoidal relief suppositories. Whitehall has been trying to get LYCD included in the rulemaking for OTC anorectal drugs. In the final rule published in August 1990, FDA deferred a decision on the status of LYCD pending review of the two clinical studies. If FDA makes a final determination that LYCD will be nonmonograph, Whitehall will have to reformulate Preparation H and Wyeth's Wyanoids. The additional data involve use of LYCD as a wound-healing agent under FDA's OTC Skin Protectant Drug Products Monograph, but Whitehall argues that the data can be extrapolated to support effectiveness for anorectal use. "Findings as to the effectiveness of ingredients under the OTC Skin Protectant Drug Products Monograph are directly relevant to the suitability of ingredients for inclusion in anorectal products," Whitehall's letter states. "Many of the Category I ingredients in the tentative final Skin Protectant Drug Products Monograph have likewise been classified as Category I in the Anorectal Monograph." Whitehall already has submitted data from two LYCD studies conducted by Jerold Kaplan, MD, Alta Bates Hospital, Berkeley, under the Skin Protectant Monograph. After reviewing the data, FDA's Office of OTC Drug Evaluation informed the company that if the Kaplan results could be "maintained in another independent study, this would satisfy the effectiveness criteria for general recognition of LYCD as an OTC wound healing aid," Whitehall said (emphasis FDAs). The letter further argues that FDA should keep the status of LYCD vis a vis the Anorectal Monograph open until the agency makes a final determination about the ingredient's use as a wound healer under the Skin Protectant Monograph. "It would make no regulatory sense to order LYCD's exclusion from OTC hemorrhoidal products when it is close to achieving Category I status as a wound healer appropriate for treatment of comparable skin conditions on body surfaces in general," Whitehall maintained. The letter does not directly address the deficiencies cited by FDA regarding the two earlier anorectal studies. "It is regrettable that the two clinical tests relating to relief of subjective symptoms...have been found unacceptable by the agency," Whitehall states. "However...there is substantial doubt whether studies of such subjective symptoms are needed or can be as relevant as studies specifically dealing with LYCD's wound-healing properties."

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