BEIJING, May 12 (Xinhuanet) -- A nicotine-free drug
shown to help more than one in five smokers quit the habit was approved
Thursday by the U.S. Food and Drug Administration (FDA), adding another option
to the limited pool of effective stop-smoking prescription medicines.
The drug, called Chantix, received a
"priority review" by the FDA, meaning it was approved within six months rather
than in the usual 10-month review period, for its demonstrated
effectiveness in clinical trials.
"We did a priority review because at the time the
application was filed, a preliminary review of the efficacy indicated that
smokers treated with Chantix may have a superior rate of smoking cessation
compared to another currently approved smoking cessation product, which was
Zyban," said Dr. Curt Rosebraugh, the FDA's deputy director for the Office of
Drug Evaluation II and Center for Drug Evaluation and Research.
Unlike Zyban, which is an antidepressant, Chantix acts at
the same sites in the brain as nicotine.
It may help people who want to quit smoking in two ways:
by providing some nicotine effects to ease withdrawal symptoms, and by blocking
the effects of nicotine from cigarettes if they resume smoking.
In 12-week clinical trials, 44 percent of patients taking
Chantix had quit smoking after four weeks, compared with 30 percent taking Zyban
and 17 percent taking a placebo, Rosebraugh said.
The drug comes in tablet form and is not recommended
for pregnant smokers, smokers younger than 18, or use with other
smoking-cessation products. Enditem
(Agencies)
