Axsome Starts Phase 3 Trial in Major Depressive Disorder

  Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).

PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) 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 (300 mg) or placebo for 6 weeks. The primary endpoint will be change in the Montgomery Åsberg Depression Rating Scale (MADRS).

https://www.biospace.com/article/releases/axsome-therapeutics-initiates-paradigm-phase-3-trial-of-solriamfetol-for-the-treatment-of-major-depressive-disorder/