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FDA Approves Pfizer Smoking Cessation Drug
  Dow Jones - May. 11, 2006 By Jennifer Corbett Dooren
WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said Thursday it approved a new type of prescription drug by Pfizer Inc. (PFE) to help people quit smoking.
The drug, varenicline, is designed to block receptors in the brain that are linked to an addiction to nicotine, the key ingredient in cigarettes. It is unlike other treatments such as patches or gums that deliver nicotine without the use of tobacco products. The drug will be sold under the brand name Chantix.
The FDA approved the drug under its priority review mechanism, which cuts about four months off the typical drug review time and is usually reserved for drugs the agency deems would be a "significant improvement" compared with existing treatments.
"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction," said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "Chantix 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 drug is designed to reduce the severity of a smoker's craving and the withdrawal symptoms from nicotine. In cases where a person might resume smoking during treatment, the drug helps block the effect of nicotine and could diminish the sense of satisfaction associated with smoking, thereby helping to break the cycle of nicotine addiction.
The agency said effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included 3,659 chronic cigarette smokers who were treated with the drug.
Five of the six studies were random, controlled clinical trials in which Chantix was shown to be superior to a placebo, or a fake drug, in helping people quit smoking. In two of the five studies, Chantix-treated patients also were more successful in giving up smoking than patients treated with Zyban, a prescription drug by GlaxoSmithKline PLC (GSK) that is also designed to help people stop smoking.
Three of the Chantix studies were presented last November at the American Heart Association's annual meeting, and they showed that using varenicline doubled the chances that people would quit smoking. However, the studies also showed that many smokers relapsed after about a year - a common problem among people trying to kick the habit.
For example, Curt Rosebraugh, deputy director of an FDA drug review division said, two of the studies that compared Chantix to Zyban and a placebo showed that at the end of a year about 22% of Chantix users had remained off of cigarettes, compared to 16% on Zyban and 10% on placebo.
The FDA said the approved course of Chantix treatment is 12 weeks. But it is recommended that patients who were able to quit smoking after that time stay on treatment for another 12 weeks.
The most common side effects of Chantix seen in clinical trials were nausea, headache, vomiting, flatulence, insomnia, abnormal dreams, and dysgeusia, or a change in taste perception.
According to the Centers for Disease Control and Prevention, about 44.5 million adults in the U.S. smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.
In early trading Thursday, Pfizer shares were up 6 cents at 25.10.
Chantix is the fourth new Pfizer medicine to receive FDA approval this year. The agency has approved Exubera for diabetes, Eraxis for the treatment of candidemia infections, and Sutent for the treatment of advanced kidney cancer and gastrointestinal stromal tumors.
Chantix is pending approval from European regulators.
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