ZACKS·2026-01-16 17:15Core Insights - Axsome Therapeutics (AXSM) has initiated a phase III study named FORWARD to evaluate AXS-14 (esreboxetine) for managing fibromyalgia, marking a significant step in its drug development process [1][8] - AXS-14 is an investigational oral drug aimed at increasing norepinephrine levels in the brain to alleviate chronic pain and related symptoms associated with fibromyalgia [1] Study Details - The FORWARD study is a phase III double-blind, placebo-controlled withdrawal trial involving patients with fibromyalgia, where participants who respond to treatment during a 12-week open-label period will be randomized to either continue AXS-14 at 8 mg once daily or switch to placebo for up to 12 weeks [2] - The primary endpoint of the study is to measure the time from randomization to the loss of therapeutic response [2][8] Market Performance - Over the past year, AXSM's shares have increased by 89.4%, significantly outperforming the industry average rise of 18.7% [3] Regulatory Background - Axsome submitted a new drug application (NDA) for AXS-14 for fibromyalgia in May 2025, which was delayed from an earlier timeline of the first quarter of 2024 [5] - In June 2025, the FDA issued a Refusal to File (RTF) letter regarding the NDA, citing inadequacies in one of the placebo-controlled studies, prompting Axsome to initiate the FORWARD study to address these concerns [6][8] Disease Context - Fibromyalgia is a chronic neurological pain disorder affecting approximately 17 million people in the United States, characterized by widespread pain, fatigue, sleep disturbances, and other symptoms [7]