Axsome Therapeutics, Inc. has made a significant announcement regarding the initiation of the paradigm Phase 3 trial of solriamfetol for the treatment of major depressive disorder (MDD). The trial, which has just dosed its first patient, 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 the change in the Montgomery Åsberg Depression Rating Scale (MADRS).
Major depressive disorder (MDD) is a debilitating, chronic, biologically based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, which impairs social, occupational, educational, or other important functioning. It is estimated that about 8.3% of U.S. adults, or approximately 21 million, experience MDD each year. The World Health Organization (WHO) has highlighted depression as the leading cause of disability worldwide and a major contributor to the overall global burden of disease. Nearly two-thirds of diagnosed and treated patients do not experience an adequate treatment response with currently available first-line therapy, highlighting the need for additional therapies with new mechanisms of action.
Solriamfetol, the investigational treatment being studied, is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is important to note that solriamfetol is not approved by the FDA for the treatment of major depressive disorder.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. They are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.
Following these announcements, the company's shares moved 4.4%, and are now trading at a price of $75.74. Check out the company's full 8-K submission here.
