FDA Approves Pfizer Drug To Help Smokers Quit
By JENNIFER CORBETT DOOREN
May 11, 2006 10:14 a.m.
WASHINGTON -- The Food and Drug Administration on Thursday approved a new type of prescription drug by Pfizer Inc. to help people quit smoking.
The drug, varenicline, is designed to block receptors in the brain that are linked to addiction to nicotine, which is the key ingredient in cigarettes. It's 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.
In early trading Thursday, Pfizer shares were up 20 cents, or 0.8%, at $25.24.
"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction," said Steven Galson, the 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 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 that's 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.
The FDA said the approved course of Chantix treatment is 12 weeks. However, patients who successfully quit smoking during Chantix treatment also could continue with an additional 12 weeks of Chantix treatment. (Read the FDA statement.)
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. |
