US priority review for Pfizer's varenicline

World leading drugmaker Pfizer has been granted a US Food and Drug Administration six-month priority review for the New Drug Application on its smoking-cessation medicine, varenicline tartrate, which the company intends to market under the brand name Champix.

Applying new understanding about the brain, biology and chemistry to smoking cessation, Pfizer researchers at the firm's Groton laboratories in 1993 took a wholly-new therapeutic approach to this medical condition. They specifically designed and developed a pill for smoking cessation that targets the nicotinic receptor in a unique way, the company explained, adding that varenicline is designed to activate the nicotinic receptor to reduce both the severity of the smoker's craving and the withdrawal symptoms from nicotine.

In all trials, varenicline was well-tolerated, with overall discontinuation rates similar to placebo. The most common side effects included nausea, headache, trouble with sleeping and abnormal dreams.