The FDA has sent a Refuse-to-File letter to Axsome Therapeutics in response to its new drug application for AXS-14, or esreboxetine, for the management of fibromyalgia.
The agency’s preliminary review of the application found that it was not sufficiently complete to permit a substantive review. Specifically, the FDA did not consider the second of the two placebo-controlled trials in the submission to be adequate and well controlled because its primary end point was at eight weeks and
JUNE 10, 2025