FDA Pushes Pause On Axsome Fibromyalgia Drug, New Trial Required

benzinga.com/news/fda/25/06/45842278/fda-pushes-pause-on-axsome-fibromyalgia-drug-new-trial-required

The U.S. Food and Drug Administration (FDA) sent a “refusal to file” letter to Axsome Therapeutics, Inc. (NASDAQ:AXSM) on Monday regarding its AXS-14 (esreboxetine) treatment of fibromyalgia.
The FDA states that upon preliminary review, the New Drug Application (NDA) was not sufficiently…

This story appeared on benzinga.com, 2025-06-09 16:39:11.
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