Axsome Therapeutics Initiates CLARITY Phase 3 Trial of Solriamfetol in Adults with Major Depressive Disorder with Excessive Daytime Sleepiness Symptoms

Core Insights - Axsome Therapeutics has initiated the CLARITY Phase 3 trial for solriamfetol, targeting major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms [1][2] Group 1: Clinical Trial Details - The CLARITY trial is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal study [2] - It includes an open-label treatment period followed by a randomized double-blind period, where patients who respond to treatment will be randomized to either continue solriamfetol or switch to placebo [2] - The primary endpoint is the time from randomization to relapse of depressive symptoms [2] Group 2: Major Depressive Disorder and EDS - Major Depressive Disorder (MDD) affects over 21 million adults in the U.S. and is a leading cause of disability worldwide [3] - Approximately 50% of MDD patients experience excessive daytime sleepiness (EDS), which can lead to impaired daily functioning and increased safety risks [3] - There are currently no approved treatments specifically for MDD with EDS symptoms [3] Group 3: About Solriamfetol - Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI) and is being developed for multiple conditions, including MDD with EDS [4] Group 4: About Axsome Therapeutics - Axsome Therapeutics focuses on innovative treatments for central nervous system (CNS) disorders and has a portfolio that includes FDA-approved treatments for various conditions [5] - The company aims to address significant gaps in care and improve patient outcomes through novel mechanisms of action [5]