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Pfizer smoking-cessation drug wins FDA approval
By Elaine Rigoli
Tampa, Fla., May 11 - Pfizer, Inc. has received approval from the Food and Drug Administration for Chantix (varenicline), a prescription medication approved for smoking cessation.
Chantix is specifically designed to partially activate the nicotinic receptor and reduce the severity of the smoker's craving and the withdrawal symptoms from nicotine, the company said in a news release. Moreover, if a person smokes a cigarette while receiving treatment, Chantix has the potential to diminish the sense of satisfaction associated with smoking. This may help to prevent the cycle of nicotine addiction, the release said.
The approval was based on a comprehensive clinical trial program including four pivotal trials involving more than 2,000 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 Chantix therapy (1 mg twice daily) nearly quadrupled the likelihood of quitting than those taking a placebo and had nearly twice the likelihood of quitting than those patients taking buproprion (150 mg twice daily), after the 12-week course of therapy.
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 Chantix remained smoke-free.
For those patients who quit at the end of 12 weeks, an additional course of 12 weeks treatment with Chantix resulted in a greater likelihood of long-term success in quitting smoking, the release said.
Pfizer is a pharmaceutical company based in New York.
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