Axsome Therapeutics(US:AXSM) Globenewswireยท2025-06-09 11:00Core Viewpoint - Axsome Therapeutics has received a Refusal to File (RTF) letter from the FDA regarding its New Drug Application (NDA) for AXS-14 (esreboxetine) for fibromyalgia management, indicating that the submission was not sufficiently complete for substantive review [1][2] Company Summary - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for various conditions and ongoing late-stage development programs [7] - The company aims to address significant gaps in care by developing differentiated products with novel mechanisms of action [7] Product Summary - AXS-14 (esreboxetine) is a selective norepinephrine reuptake inhibitor being investigated for fibromyalgia and other conditions, noted for its potency and selectivity compared to racemic reboxetine [5] - The drug is currently not approved by the FDA [5] Industry Context - Fibromyalgia is a chronic disorder affecting approximately 17 million Americans, predominantly women, characterized by widespread pain, fatigue, and other debilitating symptoms [6] - Current treatment options for fibromyalgia are limited, with only three pharmacologic treatments approved by the FDA [6] FDA Feedback and Next Steps - The FDA found one of the two placebo-controlled trials in the NDA submission inadequate due to its 8-week primary endpoint and flexible-dose design, while the other trial with a 12-week endpoint was deemed adequate [2] - In response, Axsome plans to conduct an additional controlled trial using a fixed-dose paradigm and a 12-week primary endpoint, expected to start in Q4 2025 [3][4]