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Home » PFIZER'S ANTI-SMOKING DRUG APPROVED IN EUROPE
PFIZER'S ANTI-SMOKING DRUG APPROVED IN EUROPE
September 29, 2006
Pfizer announced that the European Commission has approved Champix (varenicline), a drug for smoking cessation in adults. Champix will be available with a patient support plan that smokers can customize to address their individual behavioral triggers as they try to quit smoking.
Champix is believed to work by reducing the severity of the smoker's urge to smoke and alleviating many withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, the medicine has the potential to diminish the sense of satisfaction associated with smoking.
The approval was based on a comprehensive clinical trial program including four trials involving approximately 4,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, patients receiving a 12-week course of varenicline therapy (1 mg twice daily) had nearly four times the odds of quitting versus those taking placebo and had nearly twice the odds of quitting versus those patients taking bupropion SR (150 mg twice daily) at the end of the 12-week course of therapy. Patients in these studies were also provided with educational materials and received brief smoking-cessation counseling at each clinic visit. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of varenicline remained smoke-free.
The FDA approved the drug under the name Chantix in May.
KEYWORDS Drug Pipeline Alert
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