Axsome Warns on NDA Review Delay

Axsome Therapeutics is warning investors of a potential review delay for its NDA for AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). “As part of the ongoing review of our NDA for AXS-05, the FDA recently notified us that they have identified deficiencies that preclude labeling discussions at this time,” the company says “We are attempting to learn the nature of these deficiencies with the goal of addressing them, however, this development may lead to a delay in the potential approval of AXS-05.”

The NDA was submitted earlier this year and granted priority review to Axsome Therapeutics’ NDA for its AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). The company says AXS-05 is a novel, oral, investigative NMDA receptor antagonist with multimodal activity. At the time, FDA set an 8/22 user fee review action date.