"The announcement that the FDA has approved a new medication aimed at helping smokers quit is very welcome news. The medication, known as varenicline, will be marketed as Chantix and is aimed at all smokers, regardless of their level of dependence. Tobacco use now causes nearly one-third of all cancer deaths in the U.S. and is responsible for more than 440,000 deaths from all tobacco-related illnesses. Smokers, on average, die 13 years earlier than their nonsmoking counterparts.

"Chantix, which performed very well in the Phase II and III clinical trials leading up to FDA approval, 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. Until now, cessation medications were available in two categories: those that replace nicotine, using patches, gum, inhalers, nasal spray, and lozenges, and an antidepressant, Zyban. Chantix now presents a third category of medication, the first to actually target the neurobiological basis of nicotine dependence.

"Chantix works in two ways. First, it binds to nicotine receptors in the brain, blocking the full reinforcing effects of inhaled nicotine. At the same time, it slows the release of dopamine that normally provides the feelings of pleasure from smoking. In this way, the pleasure from smoking is reduced at the same time that withdrawal symptoms common to quit attempts are reduced. These two actions should reduce the dependence of the smoker on nicotine and also reduce the potential for relapse back to smoking.

"Studies so far show that over 20 percent of smokers using Chantix remained smoke-free one year, a significant improvement over current medications. But we've known for a long time that what happens in studies does not always happen in real life, so it remains to be seen whether that success rate can be maintained outside of the clinical trial environment. Nevertheless, 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.

"The news of the FDA's approval for a new smoking cessation drug reminds us once again of this country's great need to grant the FDA meaningful regulatory authority over tobacco products. If the FDA must oversee the contents in these new therapies that help smokers quit, then it is imperative that it also regulate the very products that are precipitating this need. Furthermore, as new therapies for smoking cessation enter the market, the need for cessation coverage by health insurance providers deepens. Nearly 70 percent of smokers would like to quit but cannot do it without assistance. In order to assure more quit attempts are successful and reduce the health and economic burden of tobacco on this country, smokers need access to all cessation therapies, including new line ones like Chantix."



David Sampson
Director, Media Relations
American Cancer Society
213 368-8523
david.sampson@cancer.org