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Executive Summary

BEECHAM SUCRETS: MENTHOL PROVIDES NASAL DECONGESTANT ACTIVITY that is statistically significant compared to placebo, Beecham maintained in a Feb. 10 petition to FDA. Beecham requests that 10.0 mg menthol, in a solid dosage form, be classified as Category I in the Final Monograph for OTC Nasal Decongestant Drug Products. In a previous Jan. 14 submission, Beecham presented the results of a 40 subject study comparing a lozenge containing 10 mg menthol with a placebo. "Results indicate [that] the active product (10 mg menthol) has statistically superior nasal decongestant properties compared to placebo," Beecham stated. "The superior results produced by the active formulation are due solely to the menthol content in the lozenge," the company added. Both active and placebo lozenges contained 2.4 mg hexylresorcinol. Nasal resistance was measured using posterior electronic rhinometry at regular time intervals post-dose. Beecham said "the vast majority of subjects treated with Vapor Action Sucrets experienced subjective decongestant relief following treatment. Subjects treated with placebo lozenges did not experience relief." Menthol was classified as Category III (more study) in the proposed rule for OTC nasal decongestants. The rule was published in the Jan. 15, 1985 Federal Register. Beecham specifically requests that menthol be listed under topical nasal decongestants, since the menthol lozenges have a topical effect through the release of vapors into the nose. Beecham noted that menthol was listed as Category I in the antitussive Final Monograph published in the Aug. 12, 1987 Federal Register. Menthol and hexylresorcinol, another ingredient in Sucrets, were classified as Category I in the Tentative Final Monograph for OTC oral health care anesthetic/analgesics, published in the Jan. 27, 1987 Federal Register ("The Pink Sheet" Feb. 1, p. 3).

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