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# Axsome Solriamfetol Misses Primary Endpoint
- URL: https://www.fdaweb.com/axsome-solriamfetol-misses-primary-endpoint/
- Published: 2025-04-01T12:00:00.000Z
- Updated: 2026-09-14T14:56:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158931

Axsome Therapeutics says that in the PARADIGM Phase 3 proof-of-concept trial of solriamfetol to treat major depressive disorder with and without excessive daytime sleepiness, the drug failed to meet its primary endpoint in the overall patient population. A company [statement](https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-topline-results-paradigm-phase-3?ref=fdaweb.com) says solriamfetol did not demonstrate a statistically significant change on a depression rating scale compared to placebo.

However, Axsome says, treatment in a prespecified subgroup with excessive daytime sleepiness resulted in greater improvement in depressive symptoms compared to placebo.

The company says the subgroup result gives it a potential direction for the future and says it plans to start a Phase 3 trial in major depressive disorder with excessive daytime sleepiness later this year.