Pfizer gets priority review from FDA for Champix anti-smoking medicine

New York, Dec. 21 - Pfizer Inc. said the Food and Drug Administration has granted a six-month priority review of the New Drug Application for its smoking cessation medicine varenicline tartrate, which Pfizer intends to market under the name Champix.

The FDA assigns priority review status to medicines that may provide a significant therapeutic advance over existing therapies, Pfizer noted.

"If current smoking patterns continue, the annual number of people dying of smoking-related diseases globally will double from five to 10 million deaths by 2020," said Hank McKinnell, chairman and chief executive officer of Pfizer, in a news release. "Pfizer's research and development effort for Champix represents the best of what medical innovation can bring to patients and families struggling to overcome tobacco addiction."

Varenicline targets the nicotinic receptor in the brain in a unique way to reduce both the severity of the smoker's craving and the withdrawal symptoms from nicotine.

The drug was well tolerated in trials, with overall discontinuation rates similar to a placebo. The most common side effects included nausea, headache, trouble sleeping and abnormal dreams.

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