Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for Fibromyalgia Management
Axsome Therapeutics, Inc. a biopharmaceutical company pioneering innovative treatments for central nervous system (CNS) disorders, announced today that the first patient has been dosed in the FORWARD Phase 3 clinical trial of AXS-14 (esreboxetine) for the treatment of fibromyalgia. This milestone marks a significant step in Axsome’s ongoing efforts to provide new therapeutic options for patients living with this challenging and often debilitating condition.
The FORWARD trial, formally known as Fibromyalgia Response with Esreboxetine Evaluated Using a Randomized Withdrawal Research Design, is a Phase 3, multicenter, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of AXS-14 in adults with fibromyalgia. The study features an open-label treatment period followed by a randomized, double-blind withdrawal period.
During the initial 12-week open-label phase, all enrolled patients will receive AXS-14 (8 mg) once daily. Patients who achieve a clinically meaningful treatment response during this period will then be randomly assigned in a 1:1 ratio to either continue AXS-14 or switch to a matching placebo for up to 12 weeks or until a loss of therapeutic response occurs. The trial’s primary endpoint is the time from randomization to loss of therapeutic response, providing insight into the durability of AXS-14’s effects on fibromyalgia symptoms.
Understanding Fibromyalgia
Fibromyalgia is a chronic, neurological pain disorder that affects an estimated 17 million people in the United States. It is primarily considered a disorder of central nervous system processing, resulting in heightened sensitivity to pain and other sensory stimuli. Patients with fibromyalgia often experience widespread musculoskeletal pain, persistent fatigue, sleep disturbances, depression, cognitive difficulties, and heightened sensitivity to touch, sound, and light. Other common symptoms include tingling in the hands and feet, headaches, and digestive disturbances.
The condition has profound effects on physical, emotional, and social functioning, often disrupting daily activities and overall quality of life. Fibromyalgia also imposes a significant economic burden due to lost productivity and high healthcare utilization. Despite its prevalence and impact, treatment options remain limited, and many patients continue to experience inadequate symptom relief. Alarmingly, more than half of patients discontinue their prescribed treatments within the first year due to insufficient efficacy or intolerable side effects, highlighting the urgent need for new therapies.
AXS-14: A Targeted Approach
AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor (NRI) under development for the management of fibromyalgia. Esreboxetine is the SS-enantiomer of racemic reboxetine, designed to enhance therapeutic effects while potentially minimizing side effects. By targeting norepinephrine pathways in the central nervous system, AXS-14 aims to address the core symptoms of fibromyalgia, including pain, fatigue, and cognitive dysfunction.
As an investigational therapy, AXS-14 has not yet been approved by the U.S. Food and Drug Administration (FDA). The FORWARD Phase 3 study represents a pivotal step in evaluating its potential to offer meaningful symptom relief for patients who have few effective treatment options.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company dedicated to advancing the treatment of CNS disorders through innovative science and patient-focused therapies. The company identifies critical gaps in care and develops differentiated products based on novel mechanisms of action to improve outcomes for patients with neurological and psychiatric conditions.
Axsome’s current portfolio includes FDA-approved therapies for major depressive disorder, migraine, and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea. In addition, the company has multiple late-stage clinical programs targeting serious CNS disorders that collectively affect more than 150 million people in the United States.
With a commitment to scientific innovation and patient well-being, Axsome is striving to address some of the brain’s most complex challenges, offering hope and improved quality of life to patients and their families.
Source link : https://www.axsome.com/
