RxPG News Feed for RxPG News

Medical Research Health Special Topics World
 Asian Health
 Food & Nutrition
 Men's Health
 Mental Health
 Occupational Health
 Public Health
 Sleep Hygiene
 Women's Health
 Canada Healthcare
 China Healthcare
 India Healthcare
 New Zealand
 South Africa
 World Healthcare
   Latest Research
 Alternative Medicine
 Clinical Trials
 Infectious Diseases
  Anti Cancer Drugs
  Anti-Clotting Drugs
  Fatty Acids
 Sports Medicine
   Medical News
 Awards & Prizes
   Special Topics
 Odd Medical News

Last Updated: Oct 11, 2012 - 10:22:56 PM
Varenicline Channel

subscribe to Varenicline newsletter
Latest Research : Pharmacology : Varenicline

   EMAIL   |   PRINT
FDA Approves Varenicline for Smoking Cessation

May 20, 2006 - 2:53:00 AM , Reviewed by: Priya Saxena
"Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit."

[RxPG] The U.S. Food and Drug Administration (FDA) announced today the approval of Chantix (varenicline tartrate) tablets, to help cigarette smokers stop smoking. The active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.

Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.

"Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States and is responsible for a growing list of cancers as well as chronic diseases including those of the lung and heart," said Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs. "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life."

According to the Centers for Disease Control and Prevention (CDC), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.

"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction" said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit."

The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking. These smokers had previously averaged 21 cigarettes a day for approximately 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 (bupropion).

The approved course of Chantix treatment is 12 weeks. Patients who successfully quit smoking during Chantix treatment may continue with an additional 12 weeks of Chantix treatment to further increase the likelihood of long-term smoking cessation.

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

Chantix is manufactured and distributed by Pfizer, Inc., New York, NY.

On the web: http://www.fda.gov/ 

Advertise in this space for $10 per month. Contact us today.

Related Varenicline News
FDA Approves Varenicline for Smoking Cessation
Varenicline could increase number who quit smoking

Subscribe to Varenicline Newsletter

Enter your email address:

For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

Contact us

RxPG Online



    Full Text RSS

© All rights reserved by RxPG Medical Solutions Private Limited (India)