FDA Approval

The US Food and Drug Administration (FDA) has been approved Chantix (Varenicline Tartrate) on May 11, 2006, to help Smokers to quit smoking. Varenicline Tartrate, active ingredient of Chantix, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.

Manufacturer
Chantix is developed by Pfizer Pharmaceuticals, New York.

Use
Chantix (Varenicline Tartrate) is indicated for Smoking Cessation.

Mode of Action
Chantix works 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.

Dosing
Chantix (Varenicline Tartrate) is available as 0.5mg and 1mg tablets. The approved course of treatment is 12 weeks.

Clinical Trails
Chantix effectiveness in smoking cessation was verified 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 Chantix was revealed to be greater to placebo in helping people stop smoking.

These smokers had before averaged 21 cigarettes a day for around 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).

The FDA does not recommend that Chantix be used with other smoking-cessation products.

Source: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01370.html

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