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Executive Summary

RICH-VICKS VAPORUB/VAPOSTREAM SINGLE INGREDIENT DECONGESTANT EFFICACY is demonstrated in at least two studies, the firm told FDA in a July 10 feedback meeting. Rich-Vicks presented the results of three recently completed studies evaluating the decongestant activity of camphor, eucalyptus and menthol. Two studies utilized a petrolatum ointment base while the third used a vaporizer. Rich-Vicks told FDA that it will submit the three studies to the OTC Division before the end of July for consideration in the Decongestant Final Monograph. The Decongestant Tentative Final Monograph, published in the Federal Register in January, placed the ingredients in Category Ill. The three studies, each investigator blind and parallel, looked at the decongestant peak effect and overall effect of the three ingredients alone in comparison with placebo. In the vaporizer study of approximately 220 subjects, the firm said that all three ingredients showed statistically significant superiority over steam alone in both peak and overall effect. One ointment study of 160 subjects found all three ingredients statistically superior to petrolatum alone in peak effect, but only eucalyptus statistically better in overall effect, Rich-Vicks reported. In that study, the firm noted, menthol, although not statistically superior, provided more decongestant effect than placebo, with a p value between 0.05 and 0.1. Presenting the results of a second topical study, Rich-Vicks told FDA that while none of the three ingredients showed statistically significant superiority to petrolatum alone, camphor was "directionally" better. In that study, the firm said, there was "greater variability," and "everyone seemed to respond better" than in the other studies. Noting that the OTC review panel found that "for an ingredient to be judged as contributing to a relevant symptom. . .the drug effect should demonstrate a 10% or greater difference from placebo," Rich-Vicks also presented the results of the studies in terms of percent change from placebo at various time points. In the vaporizor study, patients received active drug or steam alone continuously for two hours and were evaluated at six time points. The firm reported that in that study camphor was at least 10% superior to steam in six of six time points, eucalyptus in six of six time points, and menthol in four of six time points. FDA OTC Division Director William Gilbertson, PharmD, pointed out that the combination of the ingredients in the Vaporub and Vaposteam products would be addressed in the combination monograph and not the decongestant monograph. "What will happen is that as time goes by we'll publish the tentative final on combinations. . . in which [the ingredients] will still be Category Ill. . .and if we can we'll add something to the document reflecting that we have some data that's under review. Then we will come out at a later time with a final rule on decongestants which will. . .indicate which . . .single ingredients you can just market a product with. . .and then there will be a [final] combination document which will provide for the combinations in a suitable ointment base or inhalant."

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