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Consumer OTC Drugs

Anesta OT-nicotine oral transmucosal smoking cessation product to enter Phase III studies.

This article was originally published in The Tan Sheet

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Executive Summary

ANESTA OT-NICOTINE ORAL TRANSMUCOSAL SMOKING CESSATION PRODUCT will enter Phase III clinical trials once the Salt Lake City, Utah-based manufacturer of oral transmucosal delivery drug systems meets with FDA to determine protocol particulars, Anesta said June 17. The company hopes ultimately to market the product OTC although it is not ruling out initial availability as a prescription drug. Anesta presented Phase II trial results on June 14 at the annual Society for Research on Tobacco and Nicotine meeting in Nashville, Tenn. The Phase II efficacy trial compared OT-nicotine to a nicotine transdermal patch and nicotine polacrilex gum.

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