Medical Author: Melissa Conrad Stoppler, MD
Medical Editor: Jay W. Marks, MD
In May 2006, the U.S. Food and Drug Administration (FDA) approved the medication Chantix (varenicline tartrate) to help cigarette smokers stop smoking . Chantix received a priority FDA review because of its potential, important benefit to public health.
Varenicline tartrate is unique in that it mimics the actions of nicotine on the brain and can help both in easing nicotine withdrawal symptoms and blocking the reinforcing effects of nicotine if smoking is resumed. Two reports in the August 14/28, 2006 issue of the Archives of Internal Medicine have demonstrated the effectiveness of varenicline in both short- and long-term smokers who wish to quit smoking. The researchers report that treatment with varenicline tartrate led to response rates three times higher than placebo in smokers aged 18 to 65 who were attempting to quit smoking.
Previously available smoking cessation treatments include nicotine replacement therapy (gum, nasal spray, patches, and inhalers) and the antidepressants bupropion hydrochloride (Zyban), and nortriptyline hydrochloride. All of these treatments have limited efficacy, with success rates ranging from 7 to 30% in clinical studies. Future studies must be carried out to determine the effectiveness of varenicline (Chantix) treatment compared with each of these established smoking cessation therapies.
The recent studies also showed that varenicline (Chantix) was relatively well-tolerated by the smokers who took part in the study. Nausea was the most common side effect of the drug, and other side effects included headache, vomiting, flatulence (gas) , insomnia, abnormal dreams, and changes in taste perception.
The FDA-approved course of treatment with varenicline (Chantix) is twelve weeks. If smoking cessation is successful during the initial twelve-week treatment, a further twelve-week treatment may be given to increase the probability of long-term cessation of smoking.
Varenicline (Chantix) is manufactured and distributed by Pfizer, Inc., New York, NY.
For related information, please read the Quitting Smoking article.
References: Arch Intern Med. 2006;166:1571-1577; Arch Intern Med. 2006;166:1561-1568; FDA approves new drug for smoking cessation, FDA Consumer magazine, July/August 2006.