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 CHANTIXTM (varenicline) is an FDA approved prescription medicine to help adults stop smoking. ChantixTM is unique because it is specifically designed to activate the nicotinic receptor and reduce the severity of the smoker's craving and the withdrawal symptoms from nicotine.
HOW IT WORKS
The active ingredient in ChantixTM, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.
ChantixTM 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.
ChantixTM is unique because it is specifically designed to partially activate the nicotinic receptor and reduce the severity of the smoker's craving and the withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, ChantixTM diminishes the sense of satisfaction associated with smoking. This helps to prevent the cycle of nicotine addiction.
For more information, please visit www.chantix.com.
FROM THE FDA
FDA Approves Novel Medication for Smoking Cessation
MAY 11, 2006 - The U.S. Food and Drug Administration (FDA) announced today the approval of ChantixTM (varenicline tartrate) tablets, to help cigarette smokers stop smoking. The active ingredient in ChantixTM, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.
ChantixTM 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.
"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," said Scott Gottlieb, MD, 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."
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.
"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction" said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "ChantixTM 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."
The effectiveness of ChantixTM in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized, controlled clinical trials in which ChantixTM 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, ChantixTM - treated patients were also more successful in giving up smoking than patients treated with Zyban (bupropion).
The approved course of ChantixTM treatment is 12 weeks. Patients who successfully quit smoking during ChantixTM treatment may continue with an additional 12 weeks of ChantixTM treatment to further increase the likelihood of long-term smoking cessation.
In clinical trials, the most common adverse effects of ChantixTM were nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams, and dysgeusia (change in taste perception).
ChantixTM is manufactured and distributed by Pfizer, Inc., New York, NY.
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GONZALES