PFE's smoke cessation drug approved:
Message 22439245
From WSJ..
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. |
