Axsome's solriamfetol misses primary endpoint in Phase 3 MDD trial; subgroup with severe EDS shows improvement

Axsome Therapeutics, Inc.

Primary endpoint (change in MADRS total score) not met in overall MDD population.
In prespecified subgroup with severe EDS (ESS ≥16), solriamfetol showed greater improvements vs placebo on multiple measures.
Axsome plans to initiate a Phase 3 trial in MDD with EDS in 2025 based on subgroup results.
Safety profile consistent with established safety of solriamfetol; no new signals.
Approximately 50% of MDD patients experience EDS, highlighting unmet need.

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