FDA Rejects Axsome New Drug Application (NDA) for AXS-14 for Fibromyalgia

Axsome Therapeutics (NASDAQ: AXSM) received a Refusal to File (RTF) letter from the FDA regarding their New Drug Application for AXS-14 (esreboxetine) for fibromyalgia management. The FDA found the application incomplete, specifically citing issues with the second placebo-controlled trial's 8-week primary endpoint and flexible-dose paradigm. The first trial, using a 12-week endpoint and fixed-dose paradigm, was deemed adequate. Notably, both trials met their primary endpoints, and the FDA didn't question the positive results. In response, Axsome will conduct an additional controlled trial with a fixed-dose paradigm and 12-week primary endpoint, planned to start in Q4 2025. The drug aims to address approximately 17 million U.S. fibromyalgia patients' needs, having shown promising results in improving pain, function, and fatigue symptoms.

https://www.stocktitan.net/news/AXSM/axsome-therapeutics-provides-update-on-the-new-drug-application-nda-s92n69evrv1x.html