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Executive Summary

COCOA BUTTER EFFICACY STUDY shows "there is no evidence that cocoa butter is a better occlusive seal than any individual grade of Witepsol," a summary of the study concluded. The study is Kay-Fries' most recent submission to FDA in its effort to amend the OTC anorectal proposed monograph to include Witepsol cocoa butter substitutes derived from natural coconut and/or palm kernel oil as Category I anorectal protectants. In the comparative study, 19 grades of Witepsol, and cocoa butter were each applied to a specific site for each of 100 subjects and tested for their ability to reduce trans-epidermal water loss (TEWL). "All products were found to reduce TEWL significantly," the study concluded. "The mean reductions in TEWL for the Witepsol grades ranged from 35.7% to 52.5%. The mean reduction in TEWL for cocoa butter was 30.6%." On the average, the study summary stated, "Witepsol formed a better occlusive seal than cocoa butter," which FDA has classified as a Category I anorectal product. In response to an earlier request from FDA, Kay-Fries noted that currently marketed anorectal products containing Witepsol include Ross Labs' Tronolane suppositories (containing 99% Witepsol W-32) and Parke-Davis' Anusol-HC (containing 1.75 g per suppository Witepsol H-175) and Anusol (containing 1035.5 mg per suppository Witepsol H-15 and 690.35 mg per suppository Witepsol E-75). Kay-Fries reiterated that "the failure to include cocoa butter substitutes as Category I protectants places those more readily available and less costly ingredients at a competitive disadvantage for their primary purpose as suppository bases." The company noted that it has been "actively working with various companies on new suppository formulations for quite some time" and based on these development projects would recommend cocoa butter substitutes "be included in an anorectal preparation in concentrations of at least 40% per dosage unit."

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