Axsome doses first patient in phase 3 smoking cessation trial

Axsome Therapeutics Inc. has successfully administered the first dose of its experimental smoking cessation drug, AXS-05, in a Phase 3 clinical trial, according to a recent press release. The SUMMIT trial is a randomized, double-blind study evaluating the efficacy and safety of AXS-05, a combination of dextromethorphan and bupropion, in adults attempting to quit smoking.

Active smokers will be divided into three groups, receiving either AXS-05, bupropion, or placebo for 12 weeks. The primary goal of the trial is to determine whether AXS-05 can help patients achieve smoking abstinence by the end of the treatment period. While AXS-05 is not currently approved by the FDA for smoking cessation, it is already patented until at least 2043.

With around 34 million adults in the U.S. smoking cigarettes, and smoking responsible for 1 in 5 deaths annually, Axsome Therapeutics aims to address a significant public health issue through their drug development efforts.