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# Solriamfetol Phase 3 Trial Meets Endpoints
- URL: https://www.fdaweb.com/solriamfetol-phase-3-trial-meets-endpoints/
- Published: 2025-03-25T12:00:00.000Z
- Updated: 2026-09-14T14:56:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158888

Axsome Therapeutics says the FOCUS Phase 3 trial of solriamfetol to treat attention deficit hyperactivity disorder achieved its primary and secondary endpoints, demonstrating statistically significant improvements in symptoms and disease severity with solriamfetol compared to placebo. A company [statement](https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-focus-phase-3-trial-solriamfetol?ref=fdaweb.com) says the drug was safe and well tolerated in the trial with a side effect profile consistent with its established safety profile, with no serious adverse events reported.

The statement says solriamfetol is a dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A agonist being developed to treat attention deficit hyperactivity disorder, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.