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Executive Summary

EPHEDRINE OTC DECONGESTANT STUDIES DO NOT SUPPORT CATEGORY I status of the ingredient, FDA determined in a recent letter to Richardson-Vicks. "Based on our evaluation of the submitted data, the Division of OTC Drug Evaluation concludes that insufficient data have been provided to support upgrading ephedrine and its salts to Category I status for use as an oral nasal decongestant," the agency said. Ephedrine sulfate is the active ingredient in Rich-Vicks' OTC decongestant Vicks Vatronol nose drops. In support of a requested switch to Category I, Rich-Vicks submitted pooled study results from four investigators, results from three individual studies, and four literature references. The submissions were made in 1986 and 1987, following the Category III classification of ephedrine in the Jan. 15, 1985 tentative final monograph for nasal decongestants. FDA concluded that Rich-Vicks' "data fails to establish any statistical evidence, either in the pooled [data] or in any of the individual studies, that ephedrine is superior to the placebo control in reducing nasal congestion." For example, the agency pointed out that both subjective patient ratings and Vick Rhinomanometer data found "only sporadic statistically significant" differences in favor of ephedrine in one of the four centers of the pooled trial. FDA also concluded that only one of the three individual studies "showed some favorable results." That study, which was a double-blind, placebo-controlled (8 or 12 mg ephedrine sulfate in aqueous vehicle compared with vehicle alone), computer-randomized crossover trial in 41 patients, found "favorable results in favor of ephedrine 8 mg over placebo at 60 minutes after treatment," FDA said. However, "the ephedrine 12 mg group obtained only sporadically favorable results, an inconsistent finding." In addition, FDA reported that "the 12 mg group obtained significant results only within the first hour after treatment, while the 8 mg group did not obtain significant results until one hour after treatment."

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