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FDA REJECTS USE OF SUCROSE OCTAACETATE FOR DETERRING NAILBITING

This article was originally published in The Tan Sheet

Executive Summary

FDA REJECTS USE OF SUCROSE OCTAACETATE FOR DETERRING NAILBITING in the agency's final rule for OTC nailbiting and thumbsucking deterrent drug products published in the Sept. 2 Federal Register. The final rule, like the tentative final monograph published in September 1982, lists no ingredients as safe and effective for deterring either nailbiting or thumbsucking. "At this time," FDA noted in the final monograph, "there is a lack of data from adequate and well-controlled, double-blind studies to establish that denatonium, sucrose octaacetate, or any other ingredients are safe and effective for use as a nailbiting or thumbsucking deterrent." In its "negative monograph" rule published in May 1991, FDA included denatonium benzoate as a nonmonograph ingredient since no additional data had been submitted to the agency to support the ingredient's safety or efficacy in nailbiting or thumbsucking deterrent products. Sucrose octaacetate was the only ingredient for which FDA received data in support of monograph status. However, the agency questioned the design and results of the two clinical studies that "suggest that sucrose octaacetate has a small effect on nailbiting while being used" and determined that the studies "are not adequate" to support the ingredient's safety and efficacy. The three studies submitted to support the use of sucrose octaacetate were six-week, randomized, placebo-controlled studies from the Marquette University School of Dentistry, the Eastman Dental Center and the Tufts University School of Dental Medicine. While the Eastman study did not support effectiveness of the product, FDA noted, the Marquette and Tufts studies did "suggest some effect of sucrose octaacetate." However, the agency questioned whether the two trials qualify as "well-controlled" given that "important details" are lacking about the conduct of the studies. Specifically, FDA challenged the randomized methodology of the Tufts study, the blinding of observers in both studies, the endpoints and why study subjects' responses were not evaluated. In addition, side effects reported in the study subjects' diaries "were ignored" in the study reports and summaries, which FDA said, "did not acknowledge that unwanted effects may or may not have been present." FDA also pointed out that the three studies were designed "solely to assess the effect of sucrose octaacetate during use" and that "no attempt was made to determine the effectiveness of 'aversion therapy' in changing subjects' behavior after the drug was no longer being given." FDA also responded to a comment that suggested that nailbiting and thumbsucking are "habits" and not "diseases" and, therefore, "are not the proper subject of an OTC drug monograph." FDA asserted that "while nailbiting and thumbsucking may be habits, they are also conditions, which, if left untreated, can result in disease." As examples, FDA noted that nailbiting can lead to open wounds that are "highly susceptible to infections" and that thumbsucking can lead to dental problems. Because no monograph is being established for nailbiting and thumbsucking products, FDA is moving the effective date of the rule up six months to March 2, 1994. Companies wishing to market products for nailbiting or thumbsucking after that date will have to file an NDA or "in appropriate circumstances" submit a citizen petition to establish a monograph, FDA explained. The agency said it is "aware of several products that contain the ingredient sucrose octaacetate" that are being marketed and one product containing cayenne pepper as the active ingredient.
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