The US FDA has approved Pfizer's anti-smoking pill, Chantix (varenicline). Chantix, the first new prescription medication approved for smoking cessation in nearly a decade, received priority review designation by the FDA because of its potential to be a significant therapeutic advance over existing therapies.

According to the company release, Chantix is specifically designed to partially activate the nicotinic receptor and reduce the severity of the smoker's craving and the withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, Chantix has the potential to diminish the sense of satisfaction associated with smoking. This may help to prevent the cycle of nicotine addiction.

"Pfizer's discovery and development of Chantix demonstrates groundbreaking science leading to the first prescription treatment aimed directly at smoking cessation in nearly a decade," said Hank McKinnell, chairman and chief executive officer of Pfizer. "Smoking harms nearly every organ in the body. It is responsible for approximately one in five deaths in the US and costs the US health care system about $167 billion annually. This medical advance from Pfizer will now help many smokers end their addiction," he added. Chantix is the fourth new Pfizer medicine to receive FDA approval in 2006.

Chantix's approval was based on a comprehensive clinical trial program including four pivotal trials involving more than 2,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years.

Dr. Cheryl Oncken, a Chantix clinical investigator and associate professor of Medicine at the University of Connecticut Health Center said, "It is never too late to quit smoking. People who quit smoking before the age of 50 have one- half the risk of dying of a smoking-related illness in the next 15 years compared to those who continue smoking. Patients who are unable to quit on their own should consider seeking medical support and treatment."

In November 2005, Pfizer submitted a European marketing authorization application for varenicline for smoking cessation.