Axsome initiates part III AXS-14 FORWARD examine for the remedy of fibromyalgia
Axsome Therapeutics has initiated the FORWARD Part III trial evaluating AXS-14 (esreboxetine) for the remedy of fibromyalgia, with the primary affected person now dosed.
The FORWARD Part III trial, utilizing a randomized trial design, goals to evaluate the efficacy of AXS-14 in sufferers with fibromyalgia, a neurological ache dysfunction that impacts roughly 17 million individuals within the US.
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Extra data
The multicenter, double-blind, placebo-controlled examine consists of an open-label AXS-14 remedy interval adopted by a randomized, double-blind remedy interval.
Sufferers who reply through the preliminary 12-week open-label part can be randomized in a 1:1 ratio to obtain both AXS-14 (8 mg) as soon as each day or matching placebo for as much as 12 weeks, or till lack of therapeutic response is noticed.
The primary endpoint is the period from randomization to lack of therapeutic response.
Fibromyalgia is characterised by disturbed sleep, fatigue, melancholy, cognitive impairment, widespread ache and hypersensitivity to sensory stimuli. Different signs could embrace complications and tingling within the extremities.
The situation considerably impacts bodily, emotional and social well-being, resulting in important financial challenges and decrease high quality of life.
Though fibromyalgia is widespread and has critical penalties, obtainable remedy selections stay restricted and greater than half of sufferers discontinue remedy inside a 12 months as a result of inadequate symptom reduction or insupportable unwanted side effects.
AXS-14 is a selective norepinephrine reuptake inhibitor being investigated for the remedy of fibromyalgia. Esreboxetine is the SS enantiomer of racemic reboxetine. AXS-14 stays beneath investigation and has not but been authorized by the FDA.
Axsome develops remedies geared toward issues of the central nervous system (CNS). The corporate’s neuroscience portfolio contains FDA-approved therapies for main depressive dysfunction, extreme daytime sleepiness related to narcolepsy and obstructive sleep apnea, and migraine.
Axsome additionally advances a number of late-stage growth packages targeted on neurological and psychiatric issues that have an effect on greater than 150 million individuals within the US.
In March 2025, Axsome introduced that its Part III Focus examine evaluating Sunosi (solriamfetol) as a remedy for Consideration-Deficit Hyperactivity Dysfunction (ADHD) met its main endpoint. The examine confirmed a statistically important 45% discount in ADHD signs amongst members.
