Core Insights - Axsome Therapeutics has initiated the FORWARD Phase 3 trial for AXS-14 (esreboxetine) aimed at managing fibromyalgia, marking a significant step in addressing this chronic condition [1][2] Group 1: Trial Details - The FORWARD trial is a Phase 3, double-blind, placebo-controlled, multicenter study involving a randomized withdrawal design [2] - Patients will undergo a 12-week open-label treatment period followed by a randomized phase where they will either continue AXS-14 (8 mg) or switch to a placebo [2] - The primary endpoint is the time from randomization to loss of therapeutic response [2] Group 2: Fibromyalgia Overview - Fibromyalgia affects approximately 17 million people in the U.S., characterized by widespread pain, fatigue, and cognitive impairment [3] - The condition has a significant impact on quality of life and is associated with a considerable economic burden [3] - Current treatment options are limited, with over 50% of patients discontinuing treatment within the first year due to inadequate symptom control or side effects [3] Group 3: AXS-14 Profile - AXS-14 (esreboxetine) is a selective norepinephrine reuptake inhibitor being developed specifically for fibromyalgia management [4] - It is the SS-enantiomer of racemic reboxetine and is currently an investigational drug not yet approved by the FDA [4] Group 4: Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [5] - The company aims to address critical gaps in care and improve patient outcomes through differentiated products [5] - Axsome's mission is to tackle significant neurological and psychiatric challenges affecting over 150 million people in the U.S. [5]

Core Insights - Axsome Therapeutics, Inc. is presenting three innovative neuroscience programs at the ASCP 2025 Annual Meeting, focusing on treatments for central nervous system disorders [1][22] Group 1: AUVELITY - AUVELITY is an oral NMDA receptor antagonist approved for treating major depressive disorder (MDD) in adults, containing dextromethorphan (45 mg) and bupropion (105 mg) [3][4] - The mechanism of action for AUVELITY in treating depression is not fully understood, but it has received Breakthrough Therapy designation from the FDA for MDD [3][22] - AUVELITY is not approved for use in children and is specifically indicated for MDD [4][5] Group 2: AXS-05 - AXS-05 is being studied for its efficacy and safety in treating agitation associated with Alzheimer's disease through a Phase 3 randomized-withdrawal double-blind placebo-controlled study [2][22] - The lead author for this study is Dr. Jeffrey Cummings, Vice Chair of Research at UNLV [2] Group 3: Solriamfetol - Solriamfetol is being evaluated for excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnea, particularly those reporting anxiety and depression [2][22] - The lead author for this study is Dr. Ulf Kallweit, Assistant Professor of Neurology at Witten/Herdecke University, Germany [2]