Pfizer Inc said today that the European Commission has approved Champix(R) (varenicline), a novel pill for smoking cessation in adults. In addition, because smokers often need considerable support to quit successfully, Champix will be available with a patient support plan which smokers can customize to address their individual behavioral triggers as they try to quit smoking.

Smoking is a chronic relapsing medical condition that typically involves a physical and psychological addiction to nicotine. In Europe alone, more than 1.2 million people die each year from smoking-related diseases. In addition to the human toll, there is a significant social and economic cost associated with smoking. By 2010, the World Health Organization predicts the annual global cost of tobacco-related illness will be approximately $500 billion, with Europe accounting for up to $165 billion of this sum. While most smokers recognize the significant health risks associated with smoking, research shows that without adequate behavioral therapy and environmental support, most smokers relapse within a few days of trying to quit and few are able to remain quit.

"Champix provides a unique and new treatment that was specifically designed to help people stop smoking," said Dr. Michael Berelowitz, Pfizer Worldwide Medical. "Most smokers do not continue to smoke out of choice, but because they are addicted to nicotine in tobacco. Prior research has shown that the combination of behavior counseling and drug therapy is often more effective and cost-effective as health interventions than attempting to quit unaided. To meet these needs Pfizer will go beyond offering a new treatment by also providing customized behavioral support through a program designed to help smokers in the quit process."

Discovered and developed by Pfizer, Champix is specifically designed as an aid to smoking cessation. It is believed to work by reducing the severity of the smoker's urge to smoke and alleviating many withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, the medicine has the potential to diminish the sense of satisfaction associated with smoking.

Many European governments have instituted tobacco control policy changes that help create a more supportive environment for smokers who want to quit. These policies include bans on tobacco advertising and sponsorship, stronger public health warning labels, and smoking bans in all workplaces, including restaurants, bars and pubs. Comprehensive workplace smoking bans have already been approved in Ireland, Italy, Malta, Norway, England, Scotland, Belgium and Lithuania. Similar policies are being considered in France, Germany and other countries.

"Public health campaigns have increased people's understanding of the harmful health effects of smoking so that smokers are educated and more motivated to quit. In addition, more smokers are trying to quit today as a result of smoke-free policies in Europe and they need our support," said Professor Bertrand Dautzenberg, Service of Pneumology and Intensive Care, Hospital Pitie-Salpetriere, Paris. "With Champix's approval, healthcare professionals and smokers have a new treatment advance to help address this challenging addiction."

The approval of Champix(R) (varenicline) was based on a comprehensive clinical trial program including four pivotal trials involving approximately 4,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, patients receiving a 12-week course of varenicline therapy (1 mg twice daily) had nearly four times the odds of quitting versus those taking placebo and had nearly twice the odds of quitting versus those patients taking bupropion SR (150 mg twice daily), at the end of the 12-week course of therapy. Patients in these studies were also provided with educational materials and received brief smoking-cessation counseling at each clinic visit. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of varenicline remained smoke-free. For those patients who quit at the end of 12 weeks with varenicline, a separate study showed that an additional course of 12 weeks treatment with varenicline resulted in a greater likelihood of long-term success in quitting smoking.

In trials, varenicline was generally well tolerated, with overall discontinuation rates similar to placebo (11.4% for varenicline vs. 9.7% for placebo). The most common side effects included nausea, abnormal dreams, headache, insomnia, constipation, gas and vomiting.

This medication, varenicline, received U.S. Food and Drug Administration approval as an aid to smoking cessation treatment in May 2006 (with tradename Chantix(TM) (varenicline) in the United States).

Pfizer Inc