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Pfizer’s anti-smoking pill approved by FDA

The FDA has given its approval for Pfizer to begin marketing and distributing its anti-smoking pill Chantix.

Chantix' 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.

In two identically designed studies, patients receiving a 12-week course of Chantix therapy (1mg twice daily) nearly quadrupled the likelihood of quitting than those taking placebo and had nearly twice the likelihood of quitting than those patients taking GlaxoSmithKline's Zyban (150mg twice daily), after the 12-week course of therapy.

When smokers inhale smoke from a cigarette, nicotine reaches the brain within seconds and binds to nicotinic receptors, which activates the reward pathway in brain circuitry. This stimulates the pleasure center in the brain. The initial effects recede quickly and a cycle of craving and withdrawal takes hold.

Chantix is unique because it 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 CEO 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.”