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WHITEHALL SEEKING PREPARATION H LYCD CHARACTERIZATION RESULTS

Executive Summary

WHITEHALL SEEKING PREPARATION H LYCD CHARACTERIZATION RESULTS from Battelle Institute to support its continuing attempt to move the active ingredient in its OTC hemorrhoidal to Category I status as a wound healing aid. Whitehall says results of the Battelle review will be provided to the agency by the end of the year. The company informed FDA of the Battelle project in an August 14 data submission to the agency on LYCD (live yeast cell derivative). FDA had told Whitehall in June 1987 that information on the characteristics of LYCD and on the processes used to make it would be necessary for final classification in the OTC review ("The Pink Sheet" July 6, 1987, T&G-4). The firm told FDA that it has contracted with Battelle "to prepare a comprehensive plan to elucidate and characterize the active component(s) in LYCD." Whitehall noted that it will submit the results of the characterization to both the OTC Anorectal Drugs and Skin Protectant Drugs tentative final monographs to gain Category I status for the ingredient as a wound-healing agent. In support of Category I status for LYCD in the Anorectal monograph, the company filed two double-blind, randomized clinical studies comparing a hemorrhoidal ointment containing 2,000 units per ounce of LYCD with the same ointment without LYCD in the relief of hemorrhoidal discomfort. One of the clinicals was a one-hour study involving 40 patients who had external hemorrhoidal symptoms of less than two days duration. These patients were randomized to receive one application of either the LYCD or the control ointment. At designated times, the patients evaluated the degree of hemorrhoidal irritation, burning, and the degree of hemorrhoidal pain relief, and at the end of the study they made a global assessment of treatment efficacy. The firm reported that "after the five-minute time point, the LYCD-containing ointment was statistically significantly more effective than control at all time points on all scales (irritation, burning, and relief) except at 15 minutes on the irritation scale, where there was numerical superiority." In the global evaluation, "65% of the patients in the LYCD group rated the medication 'excellent', compared to none in the control group." To confirm the results of the first clinical, a second study was conducted using a similar methodology, but the investigation period was extended to two hours and a total of 100 patients were enrolled. "The reduction in irritation was statistically significantly greater for the LYCD-containing ointment than for the ointment base at all time points," the study notes. The mean scores of the global assessment ratings, in which patients rated the effectiveness of their treatment on a scale from one (poor) to 10 (excellent), were "6.6 and 4.3 for the LYCD-containing ointment group and the control group, respectively." The second study notes that "the efficacy of the base alone appeared to peak at 40-50 minutes, then declined, as the topical demulcent effect wore off. The drug-effect curve of the LYCD-containing ointment, on the other hand, appeared to peak after approximately 60 minutes, without a subsequent decline in efficacy." Whitehall pointed out that it has previously conducted and filed with FDA clinical studies of LYCD in the healing of skin grafts and skin abrasions as part of the Skin Protectant rulemaking ("The Pink Sheet" Feb. 18, 1985, T&G-1). The company also noted that when FDA published the Anorectal TFM in August 1988, it included the skin-healing studies in the administrative record of the Anorectal rulemaking. Although the TFM lists LYCD as Category III, the preamble says that FDA is reviewing results from clinical trials that could move the ingredient to Category I as a wound-healing agent ("The Pink Sheet" Aug. 15, 1988, p. 10).
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