Axsome Therapeutics Initiates SUMMIT Phase 3 Trial of AXS-05 in Smoking Cessation

NEW YORK, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the first patient has been dosed in the SUMMIT Phase 3 trial of AXS-05 for smoking cessation.

SUMMIT (Studying NMDA and Sigma-1 in Smoking Cessation Treatment) is a Phase 3 randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 as a smoking cessation treatment in adults. Active smokers will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for approximately 12 weeks. The primary endpoint will be smoking abstinence at the end of the 12-week treatment period.