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FDA Approves New Stop-Smoking Drug

April 8, 2005

• Turning The Tables On Big Tobacco • Senate Approves Bill For FDA Tobacco Regulation • Florida Smoker's Widow Awarded $30 Million • Court Finds Tobacco Companies Lied About Smoking Dangers • California Reinstates Tobacco Fraud Class Action • House Votes to Give FDA Regulatory Power Over Tobacco • Massachusetts Okays Cigarette Class Action Against Philip Morris • House Bill Would Give FDA Tobacco-Regulating Power • Tobacco And Alcohol Worse in Combination • Menthol Cigarettes May Be More Addictive • Supreme Court Clears Suits Over Light Cigarettes • Adult Smoking Rates Show Slight Drop • Racial Disparities Increasing For Cancers Unrelated to Smoking • Not Enough Doctors Trained to Help Smokers Quit • Secondhand Smoke May Hurt Children More Than Adults • Bank Stopped From Enabling Online Tobacco Sales • Study Finds Big Tobacco Exploiting Ad Ban Loophole • Do Tobacco Firms Cut Menthol to Hook Young Smokers? • Wegmans, DeCicco Markets Ditch Cigarettes • Secondhand Smoke Linked To Hospital Admissions • Anti-Smoking Drug Chantix Linked to Seizures, Heart Problems, Diabetes • Congress Moves To Tighten Tobacco Controls • Toddlers Affected Most By Secondhand Smoke at Home • Tobacco 'Innovations' Aimed at Younger Smokers • Heart Attacks Drop After Smoking Ban in Italy • Physician Highlights Hazards of Bartending • Anti-Smoking Suit Targets Restaurants • Smoking Linked to Sleep Disturbances • States Challenge R.J. Reynolds Cigarette Ads • Smokers Cost Taxpayers $10 Billion • Secondhand Smoke a Serious Health Risk • Would Women Rather Smoke Than Get Fat? • Kroger Agrees to Curb Tobacco Sales to Minors • No More Free Smokes in California • Second-Hand Smoke Tied to Lower Test Scores • Secondhand Smoke Bad for Pets • Researchers Link Smoking To Dementia • Smoking Turns On Genes -- Permanently • Bill Targets Online Cigarette Sellers • UK Tries Nicotine Patches on Pregnant Smokers • More Toxins Found in Smokers' Children --- • More about Smoking & Health

The Food and Drug Administration has approved Chantix tablets to help cigarette smokers kick the habit.

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, Deputy Commissioner for Medical and Scientific Affairs.

According to the Centers for Disease Control and Prevention, 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 FDA says the effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3,659 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.

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