India, June 9 -- Shares of Axsome Therapeutics, Inc. (AXSM) were losing around 4 percent in the pre-market trading on the Nasdaq after the firm Monday announced that it has received a Refusal to File or RTF letter from the U.S. Food and Drug Administration for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.
In response to the FDA's feedback, Axsome plans to conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA. Axsome anticipates initiating the trial in the fourth quarter of 2025.
Fibromyalgia is a chronic debilitating disorder that causes widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment...