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Title: Data Show Varenicline Provides Smokers New Hope to Quit Smoking

"Data Show Varenicline Provides Smokers New Hope to Quit Smoking"

Studies Published in JAMA Show Chantix Significantly Increases Likelihood of Quitting Over Most Commonly Used Prescription Medication NEW YORK, NY-- July 5, 2006 -- Chantix(TM) (varenicline) was shown to be effective with a favorable safety profile as an aid to smoking cessation treatment, according to three pivotal studies published in this week's Journal of the American Medical Association. Chantix, the first new prescription smoking cessation medication approved in nearly a decade, received U.S. Food and Drug Administration approval on May 10. Chantix is expected to be available in U.S. pharmacies in August. Because smokers need considerable support to successfully quit, Chantix will be available to patients with a support program designed to help address behavioral components of smoking dependence. This personalized program will be offered at no additional cost and easy to use. "According to the World Health Organization, every eight seconds a person dies of a smoking-related disease -- almost as quickly as someone else takes up smoking for the first time," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Chantix represents a significant new discovery for smokers who are trying to quit." Data show that approximately 44% of patients treated with Chantix (1mg twice a day) quit smoking by the end of the 12-week treatment period versus 30% who used buproprion SR (150mg twice a day) and 18% who used placebo. In an additional phase III clinical trial, patients who remained quit after 12 weeks of treatment with Chantix were randomized to receive an additional 12 weeks of treatment with Chantix or placebo. At the end of 24 weeks, 70.5% of patients on Chantix continued to abstain from smoking compared to 50% who switched to placebo. In trials, Chantix was generally well tolerated with overall discontinuation rates similar to placebo. The most frequent side effects included nausea, headache, trouble sleeping and changes in dreaming. In November 2005, Pfizer submitted a European marketing authorization application for varenicline for smoking cessation. SOURCE: Pfizer

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