Axsome Begins Phase 3 Trial of Solriamfetol for Major Depression

Axsome Therapeutics, a biopharmaceutical firm, has initiated the first patient dosing in a Phase 3 clinical trial for solriamfetol, a potential treatment for major depressive disorder (MDD). The trial, known as PARADIGM, is a randomized, double-blind, placebo-controlled study that will involve approximately 300 adult participants. These individuals will be evenly assigned to receive either solriamfetol at a dosage of 300 mg or a placebo for a duration of six weeks. The primary metric for assessing the drug's effectiveness will be the change in scores on the Montgomery Åsberg Depression Rating Scale (MADRS).

MDD is a severe and chronic condition that affects an individual's mood, pleasure perception, energy levels, and can lead to feelings of guilt and worthlessness. It can significantly impair various aspects of a person's life, including social, occupational, and educational functions. In extreme cases, it can even lead to suicide. The disorder is widespread, with an estimated 8.3% of U.S. adults, which equates to around 21 million people, suffering from it annually. The World Health Organization (WHO) has identified depression as the leading cause of disability globally, significantly contributing to the overall disease burden worldwide. A significant portion of patients diagnosed with MDD do not find adequate relief with current first-line therapies, underscoring an urgent need for new treatment options.

Solriamfetol, the drug under trial, is a unique compound that inhibits the reuptake of dopamine and norepinephrine while also acting as an agonist for trace amine-associated receptor 1 (TAAR1). It is not currently approved by the FDA for treating MDD.

Axsome Therapeutics is dedicated to developing innovative treatments for central nervous system (CNS) conditions that lack sufficient therapeutic options. The company is focused on creating novel mechanisms of action to transform the treatment landscape for CNS disorders. Their mission is to develop products that can significantly improve patient outcomes and offer physicians new tools for treatment.