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FDA OKs New Quit-Smoking Drug

Chantix Eases Withdrawal Symptoms and Blocks Nicotine's Effects

Chantix Trials

The effectiveness of Chantix in smoking cessationsmoking cessation was demonstrated in six clinical trials, which included 3,659 chronic cigarette smokers who were treated with Chantix.

Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smokingquit smoking. These smokers had previously averaged 21 cigarettes a day for about 25 years.

In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban, states the FDA's news release.

In those two studies, both Chantix and Zyban were superior to placebo. After 12 weeks of treatment, a bigger proportion of Chantix users had quit smoking.

But 50 weeks after treatment stopped, the differences between the percentage of people who had used Chantix or Zyban and were still smoke-free weren't statistically significant, meaning they may have been due to chance, notes Rosebraugh.

In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomniainsomnia, abnormal dreams, and dysgeusia (change in taste perception), according to the FDA.

Chantix is made and distributed by the drug company Pfizer.

American Cancer Society's Comments

The American Cancer Society issued a statement on Chantix. The statement is attributed to Thomas J. Glynn, PhD, the American Cancer Society's director for cancer and science trends and for international tobacco programs.

In the statement, Glynn calls the drug's approval "very welcome news."

While noting that long-term results in real-life settings aren't yet clear, Glynn says "if smokers comply with the Chantix treatment regimen and take advantage of an accompanying behavioral treatment program, we would expect success rates to be high and, equally important, that smokers and those who treat them will have an important new tool to call upon."

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