NEW YORK - Axsome Therapeutics, Inc. (NASDAQ: NASDAQ:AXSM), a biopharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, today announced the initiation of a Phase 3 clinical trial for solriamfetol, a potential new treatment for major depressive disorder (MDD). The trial, named PARADIGM, is designed to evaluate the efficacy and safety of the drug in adults with MDD.
The PARADIGM trial is a randomized, double-blind, placebo-controlled study that will involve approximately 300 patients across multiple centers. Participants will be assigned in equal numbers to receive either a 300 mg dose of solriamfetol or a placebo over a period of 6 weeks. The primary measure of the study's success will be the change observed in the Montgomery Åsberg Depression Rating Scale (MADRS), a widely used clinical assessment tool for depression.
Major depressive disorder is a significant public health concern, affecting an estimated 8.3% of U.S. adults annually, according to the National Institutes of Health. The World Health Organization identifies depression as the leading cause of disability globally. Current first-line therapies for MDD are inadequate for nearly two-thirds of treated patients, emphasizing the need for new treatment options.
Solriamfetol operates as a dopamine and norepinephrine reuptake inhibitor and also acts as an agonist at the trace amine-associated receptor 1 (TAAR1). It is important to note that the U.S. Food and Drug Administration has not yet approved solriamfetol for the treatment of MDD.
Axsome Therapeutics is committed to addressing unmet medical needs in CNS disorders by developing therapies with novel mechanisms of action. The company has highlighted the importance of this trial in potentially providing a new therapeutic option for physicians and improving the lives of patients with MDD.
The information regarding this trial is based on a press release statement from Axsome Therapeutics.
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