Axsome Therapeutics dosed the first patient in its SUMMIT Phase 3 clinical trial. This trial evaluates AXS-05 as a potential smoking cessation treatment.
The trial will assess AXS-05's efficacy and safety. It compares AXS-05 to a placebo and bupropion, an existing smoking cessation aid.
The study will enroll adult smokers. Participants will receive treatment for approximately 12 weeks. The primary goal is smoking abstinence at the end of the treatment period.
AXS-05 combines dextromethorphan and bupropion. The U.S. has already approved AXS-05 under the brand name Auvelity. Auvelity treats major depressive disorder and agitation related to Alzheimer's disease.
This trial aims to expand the drug's approved uses. It targets smoking, a public health issue affecting an estimated 34 million U.S. adults.