FDA OKs New Quit-Smoking Drug

May 11, 2006 -- The FDA has approved a new drug to help cigarette smokers quit smokingquit smoking.

The drug is called Chantix. It comes in tablet form and is not recommended for pregnant smokers, smokers younger than 18, or use with other smoking-cessation products, the FDA's Curt Rosebraugh, MD, MPH, told reporters at a teleconference.

Rosebraugh is the deputy director of the Office for Drug Evaluation II at the FDA's Center for Drug Evaluation and Research.

The active ingredient in Chantix, varenicline tartrate, is a new drug that got a priority FDA review; it took six months for approval instead of the usual 10 months for routine reviews.

"We did a priority review 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 cessationsmoking cessation compared to another currently approved smoking-cessation product, which was Zyban," Rosebraugh says.

12 Weeks of Treatment

The approved course of Chantix treatment is 12 weeks, but longer treatment may help some patients. In addition to Chantix, counseling is also recommended as part of the treatment program.

"The way that the label is written is that if you take 12 weeks of therapy and successfully stop smoking at the end of that 12 weeks, an additional 12-week course of treatment is recommended to further increase the likelihood of long-term smoking cessation," Rosebraugh says.

Chantix acts at the same sites in the brain as nicotine. It may help people who want to quit smoking in two ways: by providing some nicotine effects to ease withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.

"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction," says Steven Galson, MD, MPH, in the FDA news release. Galson directs the FDA's Center for Drug Evaluation and Research.

"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," Galson says.