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Nabi NicVax Phase II data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Nabi's nicotine conjugate vaccine NicVax yielded a 33% quit rate in smokers in a Phase II study, compared to 9% for placebo, the company announces Sept. 28. The vaccine was tested at three doses, with the highest dose (200 mcg) producing the 33% cessation rate. "In addition, results showed a substantial reduction in average cigarette consumption in smokers who received the highest dose…versus lower doses or placebo," the company reports. Nabi expects NicVax to enter Phase III studies in the second half of 2005. The firm says the product has the potential for use as both an initial smoking cessation aid as well as longer-term relapse prevention. By producing antibodies to bind to nicotine, NicVax is designed to prevent nicotine from entering the brain, "thereby preventing the 'rush' that occurs when nicotine binds to receptors in the brain," the company explains. Sanofi-Aventis plans to submit an NDA for Acomplia (rimonabant) for smoking cessation second-quarter 2005 (1Pharmaceutical Approvals Monthly March 1, 2004, In Brief)...

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