other material
confidence high
sentiment positive
materiality 0.60
Axsome doses first patient in PARADIGM Phase 3 trial of solriamfetol for MDD
Axsome Therapeutics, Inc.
- First patient dosed in Phase 3 PARADIGM trial of solriamfetol for major depressive disorder.
- Randomized, double-blind, placebo-controlled trial with ~300 patients (1:1 ratio, 300 mg or placebo for 6 weeks).
- Primary endpoint is change in Montgomery-Åsberg Depression Rating Scale (MADRS).
- Solriamfetol is an investigational treatment; Axsome specializes in CNS disorders.