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Axsome Therapeutics Initiates CLARITY Phase 3 Trial of Solriamfetol in Adults with Major Depressive Disorder with Excessive Daytime Sleepiness Symptoms
NEW YORK, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the first patient has been dosed in the CLARITY Phase 3 trial of solriamfetol in the treatment of major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms. CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with MDD with EDS symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period. Patients achieving a treatment response during the open-label period will be randomized in a 1:1 ratio to continue solriamfetol or to switch to placebo. The primary endpoint will be the time from randomization to relapse of depressive symptoms. About Major Depressive Disorder with Excessive Daytime Sleepiness Symptoms Major Depressive Disorder (MDD) is a serious, common, biologically based psychiatric disorder and a leading cause of disability worldwide, impacting over 21 million adults in the U.S. alone.1-3 It is characterized by depressed mood and loss of interest or pleasure, as well as disturbed sleep or appetite, impaired cognitive function, feelings of guilt and worthlessness, and low energy, among other symptoms. MDD can result in severe functional impairments that interfere with all aspects of life, and in severe cases, can lead to suicide.1 Excessive daytime sleepiness (EDS) is a common symptom in individuals with MDD that affects approximately 50% of patients and is associated with a greater risk of major depressive episodes.4 Patients with EDS have difficulty maintaining wakefulness and exhibit an increased tendency to fall asleep during the day, including in inappropriate circumstances, resulting in impaired daily functioning and increased safety risks. There are currently no approved treatments for MDD with EDS symptoms. About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime slee...