Benzinga | Aug 9, 2021 07:20AM EDT

Axsome Therapeutics Says On Jul. 30 Received FDA Letter Regarding NDA For AXS-05 Stating FDA Has 'identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time'

AXS-05

AXS-05 (dextromethorphan-bupropion) is Axsome's novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: major depressive disorder (MDD), Alzheimer's disease (AD) agitation, and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designations for MDD and for AD agitation.

* Depression: Axsome's New Drug Application (NDA) for AXS-05 for the treatment of MDD was granted Priority Review and is currently under review by the FDA. On July 30, 2021, the Company received a letter from the FDA stating that it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The letter stated further that the notification does not reflect a final decision on the information under review. The letter did not state what the deficiencies are. In response to the Company's inquiries regarding the nature of the deficiencies since receipt of the letter, the FDA has informed the Company that their review is ongoing,but have not yet communicated any details regarding the nature of the deficiencies. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is August 22, 2021. Axsome has completed the MERIT trial, a Phase 2, randomized, double-blind, placebo-controlled, relapse prevention trial of AXS-05 in treatment resistant depression (TRD) patients. In a separate release issued this morning, Axsome announced that AXS-05 met the primary and key secondary endpoint in the trial. AXS-05 substantially and significantly delayed the time to relapse of depression (p=0.002, primary endpoint), and prevented relapse of depression (p=0.004, key secondary endpoint), compared to placebo.