Beecham phenol/dyclonine OTC feedback meeting
Executive Summary
On Dec. 6, the firm presented a protocol it will submit in support of a long-lasting relief claim for throat and mouth soreness, according to FDA. The protocol involves a "new method" for determining the effectiveness of the anesthetic combo, that involves a programmable device to direct streams of air to the back of the throat. The combination's effect on modifying the stimulus is then measured. The agency requested that Beecham submit results of a comparison of the new method v. the "old method" of applying electric currents to the tongue. The active ingredient of Sucrets is dyclonine hydrochloride....
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