Axsome Therapeutics Announces Positive Efficacy and Safety Results from Phase 3 COMET Long-Term Trial and COMET-AU Trial of AXS-05 in Major Depressive Disorder
Safety results discussed below include all patients enrolled in the COMET trial.
- Safety results discussed below include all patients enrolled in the COMET trial.
- Efficacy results from the overall COMET trial presented below are for de novo patients only (n=611).
- Maintenance of efficacy results for roll-over patients were similar, demonstrating sustained efficacy over 12 months, and will be presented in future scientific publications.
- COMET (Clinical Outcomes with NMDA-based Depression Treatment) was a Phase 3, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in patients with major depressive disorder (MDD).