Axsome Therapeutics Inc. recently announced receiving a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-14, intended for managing fibromyalgia. The FDA found the application incomplete, specifically citing inadequacies in one of the two placebo-controlled trials due to its 8-week primary endpoint and flexible-dose paradigm. In response, Axsome plans to conduct an additional controlled trial with a fixed-dose paradigm and a 12-week primary endpoint, as requested by the FDA, and aims to initiate this trial in the fourth quarter of 2025.
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