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FDA approves Pfizer’s Smoking Cessation Drug
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            May 12, 2006 11:28 IST  
FDA has given a formal approval on Thursday, to the use of Pfizer’s new smoking cessation pill, to help smokers quit by reducing nicotine cravings and lessening withdrawal symptoms once they stop. Around 70 % of the 45 million American smokers want to give up the smoking habits, and for the first time in almost a decade, there is a new prescription option to help them.

FDA has given a formal approval on Thursday, to the use of Pfizer’s new smoking cessation pill, to help smokers quit by reducing nicotine cravings and lessening withdrawal symptoms once they stop.  Around 70 % of the 45 million American smokers want to give up the smoking habits, and for the first time in almost a decade, there is a new prescription option to help them. The FDA has sanctioned a new medication called Chantix for smoking cessation that helped about one-fifth of cigarette smokers quit the habit for a year in trials.

According to the FDA, Chantix works in different manner than older stop-smoking aids, most of which provide an alternate source of the addictive nicotine in cigarettes. It targets sites in the brain influenced by nicotine. Chantix helps people stop smoking by obstructing the pleasure they receive from smoking and reducing withdrawal symptoms as they quit.
Beside the Pfizer’s smoking cessation pill Chantix, GlaxoSmithKline Plc’s pill Zyban also is approved to help smokers quit, but how it works is not clear.

Pfizer’s two different studies revealed that smokers who took Chantix for 12 weeks were more likely than Zyban users to cease cigarettes. 44% of Chantix patients get rid of the habit, compared with 30 percent who used Zyban.

Before starting treatment, the participants had averaged 21 cigarettes a day for about 25 years. However, after one year there was a little difference between those who took Chantix and Zyban, although both groups fared better than placebo users, FDA officials reported.

Dr. Curt Rosebraugh, deputy director of the FDA office that approved Pfizer’s Chantix, reported that one study showed about 22 percent of Chantix users were smoke-free after a year, compared with 16 percent of Zyban users and 10 percent of those who got a placebo. And another study found no statistically significant difference between Zyban and Chantix users.

Smoking doesn’t just affect the smoker, but also those around them. Approximately half a million people die from smoking-related illnesses each year in the U.S.

Karen Katen - Vice Chairman of Pfizer Inc and President, Pfizer Human Health said, "As everyone knows, it is extremely difficult to quit smoking," he added, "For example, less than 7 percent of smokers who try to quit on their own achieve more than one year of abstinence. In fact, most smokers begin smoking again within a few days of attempting to quit. It takes about 10 attempts -- with or without treatment -- before the average smoker is able to quit."

She included that "Chantix is an excellent example of Pfizer’s focus on combating the human and economic cost of disease through prevention and wellness based on scientific innovation and patient support initiatives."

The Chantix, known generically as varenicline, is to be taken twice a day during a 12-week treatment.

However, the American Cancer Society welcomed the prescribed anti-smoking drug-Chantix as a new option, Thomas Glynn, the group’s director for cancer science and trends said, "But we’ve known for a long time that what happens in studies does not always happen in real life, so it remains to be seen whether that success rate can be maintained outside of the clinical trial environment."
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