Axsome Therapeutics initiates PARADIGM Phase 3 trial of Solriamfetol

Axsome Therapeutics announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder, MDD. PARADIGM is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of MDD in adults. Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol or placebo for 6 weeks. The primary endpoint will be change in the Montgomery Asberg Depression Rating Scale.