Magazine article FDA Consumer

The FDA Approves New Drug for Smoking Cessation

Magazine article FDA Consumer

The FDA Approves New Drug for Smoking Cessation

Article excerpt

In May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate) tablets to help cigarette smokers ages 18 and older stop smoking.

The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months rather than the regular review time of 10 months, says Curt Rosebraugh, M.D., M.P.H., deputy director of the FDA's Office of Drug Evaluation II. "Chantix underwent priority review," Rosebraugh says, "because at the time the application was filed, a preliminary review of the efficacy studies indicated that smokers treated with Chantix may have a superior rate of smoking cessation compared to Zyban (bupropion), another currently approved product for smoking cessation."

Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking. Rosebraugh says, "If someone slips up, they would probably not have the reinforcement that they would normally get from smoking a cigarette."

According to the Centers for Disease Control and Prevention (CDC), an estimated 45 million adults in the United States smoke cigarettes, and more than 8 million of them have at least one serious illness caused by smoking.

"Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States and is responsible for a growing list of cancers as well as chronic diseases including those of the lung and heart," says Scott Gottlieb, M.D., the FDA's deputy commissioner for medical and scientific affairs. "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life."

The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3,659 chronic cigarette smokers who were treated with varenicline. …

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