Axsome Therapeutics has initiated the FORWARD Phase III trial evaluating AXS-14 (esreboxetine) for the management of fibromyalgia, with the first patient now dosed.
The FORWARD Phase III trial, using a randomised withdrawal research design, aims to assess the efficacy of AXS-14 in patients with fibromyalgia, a neurological pain disorder affecting around 17 million individuals in the US.
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The multi-centre, double-blind, placebo-controlled study consists of an open-label AXS-14 treatment period followed by a randomised, double-blind treatment period.
Patients who demonstrate a response during the first 12-week open-label phase are randomised in a 1:1 ratio to receive either AXS-14 (8mg) once a day or a matching placebo for up to 12 weeks, or until a loss of therapeutic response is observed.
The main endpoint is the duration from randomisation to the loss of therapeutic response.
Fibromyalgia is characterised by disturbed sleep, fatigue, depression, cognitive impairment, widespread pain and hypersensitivity to sensory stimuli. Other symptoms may include headaches and tingling in the extremities.
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By GlobalDataThe condition significantly affects physical, emotional, and social well-being, leading to considerable economic challenges and a lower quality of life.
Although fibromyalgia is widespread and has serious consequences, available treatment choices remain limited, and more than half of patients stop therapy within one year because of insufficient symptom relief or unacceptable side effects.
AXS-14 is a selective norepinephrine reuptake inhibitor under investigation for fibromyalgia management. Esreboxetine is the SS-enantiomer of racemic reboxetine. AXS-14 remains investigational and is not yet approved by the FDA.
Axsome develops treatments targeting central nervous system (CNS) disorders. The company’s neuroscience portfolio includes therapies approved by the FDA for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnoea, and migraine.
Axsome is also advancing several late-stage development programmes focused on neurological and psychiatric conditions affecting more than 150 million people in the US.
In March 2025, Axsome announced its Phase III Focus trial evaluating Sunosi (solriamfetol) as a treatment for attention-deficit hyperactivity disorder (ADHD) achieved its primary endpoint. The study demonstrated a statistically significant 45% reduction in ADHD symptoms among participants.
