Axsome Therapeutics (AXSM -2.7%) confirms pivotal development status and plan for AXS-05 in the treatment of Alzheimer’s disease (AD) agitation following a successful Breakthrough Therapy meeting with the FDA.
AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is an oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist. There is currently no approved treatment for AD agitation.
Results of the meeting confirm the pivotal status of the previously completed positive ADVANCE-1 trial, and the establishment of the superiority of AXS-05 over its components.
Consequently, only one additional Phase 3 efficacy trial will be needed to support the NDA filing for approval of AXS-05 in this indication, and only a placebo control will be required.
Axsome is on track to initiate this efficacy trial in Q4. The Company also plans to launch an open-label safety extension trial of AXS-05 in AD agitation patients in Q4 to supplement the existing AXS-05 long-term safety database.
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