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CHPA Benzocaine Study Protocol Includes Consumer Research Survey

This article was originally published in The Tan Sheet

Executive Summary

Studying OTC toothache relief ingredient benzocaine in an actual use setting presents "insurmountable hurdles," the Consumer Healthcare Products Association tells FDA in an April 16 briefing document

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Benzocaine Repeat-Dosing, Three-Arm Trials Recommended By FDA’s Ganley

A three-arm benzocaine study is necessary to determine whether the existing 20% and 10% strengths are equally effective for toothache pain relief, according to FDA Division of OTC Drug Products Director Charles Ganley, MD

Eugenol Inclusion In Oral Pain Monograph Requires Actual Use Data – FDA

Both a clinical safety trial and an actual use study are necessary to support including eugenol in the oral discomfort (relief) products final monograph, FDA tells the Consumer Healthcare Products Association

Benzocaine, eugenol stratified clinical trial for oral toothache pain suggested by FDA.

OTC TOOTHACHE RELIEF STRATIFIED CLINICAL TRIAL for the ingredients benzocaine and eugenol suggested by OTC Drug Products Medical Reviewer Rosemarie Neuner, MD, at a "feedback" meeting on OTC toothache pain relief products in Rockville, Md. June 25. The agency's suggestion for a stratified trial, which would separate out patients who had ingested an internal analgesic or alcohol prior to receiving an oral toothache treatment, came in response to Mentholatum's inability to enroll patients for a protocol FDA suggested in September 1997.

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