The FDA says in a statement that the active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority review because of its potential benefit to public health.
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.
Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, says, "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."
He adds, "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life."
According to the Centers for Disease Control and Prevention (CDC), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.
Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, says, "Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction."
He says, "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."
Six clinical trials studied 3659 chronic cigarette smokers who were treated with varenicline.
Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking.
These smokers had previously averaged 21 cigarettes a day for approximately 25 years. In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban (bupropion).
