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FDA Approves New Smoking Cessation Drug

FDA gives accelerated approval to new molecular entity

THURSDAY, May 11 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has approved Chantix, a smoking cessation drug made by Pfizer, Inc. The drug was given accelerated approval because its active ingredient, the new molecular entity varenicline tartrate, can help cigarette smokers kick the habit, according to an FDA statement.

Chantix allays nicotine withdrawal by replacing some of nicotine's effects on the brain; it can also stop nicotine from affecting brain cells if smokers resume the habit. About 44.5 million U.S. adults smoke cigarettes, and 8.6 million have one serious smoking-related disease or more, according to federal data.

Six clinical studies of the drug were conducted, including 3,699 smokers. In five of the six trials, Chantix was more efficacious than placebo and in two of the trials it was more efficacious than Zyban (bupropion) for smoking cessation. The most common side effects were nausea, headache, vomiting, flatulence, insomnia, abnormal dreams and dysgeusia.

Chantix is taken in tablets, usually for 12 weeks.

"Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit," said Steven Galson, director of FDA's Center for Drug Evaluation and Research, in a statement.

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