Pfizer Japan Gets Champix Approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer Japan, Inc. received manufacturing and marketing authorization for Champix Tablet 0.5 mg/1mg (varenicline tartrate), a smoking cessation aid for nicotine-dependent  smokers.
   
Champix, Japan’s first oral smoking cessation treatment, brings about a smoking cessation effect as a non-nicotine partial agonist1 that binds to a4b2 nicotine receptors in the brain, relieving withdrawal symptoms and tobacco craving associated with smoking. If a person smokes a cigarette while receiving treatment, Champix inhibits nicotine from binding to a4b2 nicotine receptors, restricting the patient’s sense of satisfaction associated with smoking. Champix was launched under the product name of Chantix in August 2006 in the U.S. and of Champix in December 2006 in the EU.  
   
In a 12-week, randomized, double-blind, placebo-controlled study in Japanese smokers who wanted to quit smoking, the primary endpoint was 65.4% (85/130 cases) in patients receiving 1mg Champix twice-daily and 39.5% in the placebo group (51/129 cases) respectively, showing a statistically significant difference between the two groups.

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