Executive Summary

Pfizer's NDA for its smoking cessation drug varenicline tartrate has been granted a six-month priority review by FDA, the firm announces Dec. 21. The product would be marketed as an Rx drug under the brand name Champix if approved. According to Pfizer, the brain's nicontinic receptor triggers a sense of satisfaction when nicotine is inhaled, but the effects recede quickly, creating a cycle of craving and withdrawal. Varenicline is designed to activate the nicotinic receptor to "reduce both the severity of the smoker's craving and the withdrawal symptoms," the firm maintains. Pfizer notes that priority reviews are assigned to drugs "that may provide a significant therapeutic advance over existing therapies." The drug's NDA was submitted in November...