Axsome Therapeutics released phase 2 results from the COMET Treatment Resistant Depression clinical trial this morning. TRD is defined as those who had ongoing symptoms of depression despite receiving two or more antidepressants during the current major depressive episode. The results were compelling in this open label clinical trial. Below is a recap of what was discovered in the phase 2 trial.
- Mean MADRS of -20.6 improvement from baseline at week 6
- Remission from depression occurred in 43.8% of patients at week 6
- Remission was 62.3% at 6 months and 72.7% at 12 months
The mean MADRS score was 33.1 at baseline, and the adverse event profile was similar to other AXS-05 clinical trials which included, dizziness, nausea, headache, dry mouth and decreased appetite. The New Drug Application for MDD is projected to be submitted to the FDA in January. Thank you for reading.
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