Posted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA for its new drug application for AXS-14 (esreboxetine) for the management of fibromyalgia.
The FDA states that upon preliminary review, it found that the new drug application was not sufficiently complete to permit a substantive review.
