Axsome Therapeutics has dosed the first patient in the Phase 3 SUMMIT trial of AXS-05 for smoking cessation in adults. The randomized, double-blind, active- and placebo-controlled study will compare AXS-05, bupropion, and placebo over a 12-week treatment period.
The trial’s primary endpoint is smoking abstinence at the end of the 12-week treatment. AXS-05, a combination of dextromethorphan and bupropion, is currently approved in the U.S. under the brand name AUVELITY for treating major depressive disorder in adults and agitation associated with dementia due to Alzheimer’s disease. The drug is not approved for smoking cessation.
AXS-05 is covered by patents extending to at least 2043. The company has not disclosed enrollment targets or trial sites for the SUMMIT study. The trial follows prior Phase 2b results suggesting potential efficacy for smoking cessation, though detailed data from those studies has not been released.
Smoking remains a significant public health challenge in the U.S., with approximately 34 million adults smoking cigarettes. The habit accounts for one in five deaths annually and generates over $300 billion in annual costs, according to U.S. health authorities.
