Chantix anti smoking drug approved

  Article date: 2006/05/11,Chantix Works Differently Than Other Medications

Smokers will soon have a new weapon in their fight against tobacco. The US Food and Drug Administration (FDA) has approved varenicline, a drug made by Pfizer, to help people kick the habit. The drug will be sold in pill form under the name Chantix.

The approval is "welcome news," said Tom Glynn, PhD, director of cancer science and trends and director of international tobacco programs for the American Cancer Society.

"Tobacco use now causes nearly one-third of all cancer deaths in the US and is responsible for more than 440,000 deaths from all tobacco-related illnesses," he said. "Chantix offers clinicians and smokers a unique therapeutic approach to quitting and an important new tool in the effort to reduce tobacco-related cancers and other diseases."

The FDA’s deputy commissioner for medical and scientific affairs, Scott Gottlieb, MD, said, "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life."
A Different Approach to Quitting

Chantix works differently than other smoking-cessation drugs currently on the market, Pfizer said. It acts on the nicotine receptors in the brain, helping people overcome nicotine cravings and withdrawal symptoms, and lessening the pleasure they get from smoking.

But Chantix is not a nicotine replacement product like the patches, lozenges, gums, inhalers, and nasal sprays already available. It also is not an antidepressant like bupropion (Zyban), another drug already available for smoking cessation. It’s the first new prescription drug approved for quitting smoking in nearly a decade, Pfizer said.

The FDA based its approval decision on the results of 6 clinical trials involving nearly 4,000 smokers. Chantix was much better than placebo at helping smokers quit. In 2 of the studies Chantix also outperformed Zyban. Pfizer is also developing a free online and phone support program for smokers who have a prescription for Chantix to use along with the drug to help them quit.

Smokers need all the help they can get, Glynn emphasized. "Nearly 70% of smokers would like to quit but cannot do it without assistance," he said.

Side effects from Chantix included nausea, headache, vomiting, gas, trouble sleeping, and abnormal dreams.

Chantix is a pill taken twice a day for 12 weeks. Smokers who successfully quit after the first course of treatment will have the option of taking a second 12-week course, the FDA said, because that could increase their chances of staying off cigarettes for the long term. The drug should be available in the second half of this year, Pfizer said.

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