The FDA assigns priority review status to medicines that may provide a significant therapeutic advance over existing therapies. Once the FDA formally determines the application is sufficiently complete for review, the filing will move forward under priority review.
At present, less than seven percent of smokers who try to quit on their own achieve more than one year of abstinence and most relapse within a few days of attempting to quit.
“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 CEO of Pfizer. “Pfizer’s R&D effort for Champix represents the best of what medical innovation can bring to patients and families struggling to overcome tobacco addiction.”
When smokers inhale a lit cigarette, nicotine reaches the brain within seconds and binds to a nicotinic receptor which activates the reward pathway in brain circuitry. This creates a powerful sense of satisfaction. The initial effects recede quickly and a cycle of craving and withdrawal ensues.
Champix 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, Champix was well tolerated, with overall discontinuation rates similar to placebo. The most common side effects included nausea, headache, trouble sleeping and abnormal dreams.