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FDA Speeds Smoking Cessation Drug Review
Bridget M. Kuehn
JAMA. 2006;295:614.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The Food and Drug Administration (FDA) has agreed to fast track its review of an experimental smoking cessation drug that studies suggest is more effective at helping smokers quit than the antidepressant bupropion at least in the short term. The drug, called varenicline, specifically targets the brain receptors responsible for mediating the reinforcing effects of nicotine.
The FDA granted priority review status to Pfizer's new drug application for varenicline in December, according to the company. This status is granted to drugs that represent a significant improvement over existing therapies in effectiveness and/or patient compliance or a reduction in adverse events.
A pair of identical randomized double-blind, placebo-controlled studies of about 2000 smokers showed that after 12 weeks of treatment about 44% of those taking varenicline had quit smoking compared with 30% of those taking bupropion and 17.7% of those taking a placebo, according to data presented in . . . [Full Text of this Article]
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