THURSDAY, May 11, 2006 (HealthDay News) -- Pfizer's Chantix (varenicline tartrate) was approved Thursday by the U.S. Food and Drug Administration to help smokers quit by reducing the pleasure of smoking and lessening withdrawal symptoms once smokers stop.
Besides Zyban (bupropion), approved in 1997, Chantix is only the second nicotine-free drug sanctioned for the 44.5 million smokers in the United States, according to the Associated Press.
An average of better than one in five smokers who used Chantix quit smoking during six clinical trials involving more than 3,600 chronic cigarette users, the FDA said. Participants had averaged 21 cigarettes daily for 25 years. People who used Chantix were more successful in kicking the habit than those who used Zyban, the agency added.
The most frequent side effects during clinical testing included nausea, headache, flatulence, insomnia and changes in taste perception.
Chantix is approved to be taken twice daily for 12 weeks. People who stop smoking may continue with an additional 12 weeks to better their chances of remaining smoke-free, the FDA said.