Axsome Therapeutics (AXSM) reported results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder with and without severe excessive daytime sleepiness. The company stated that, in the overall patient population, the study did not show a statistically significant change on the Montgomery-sberg Depression Rating Scale total score compared to placebo, the primary endpoint.
In the prespecified subgroup of patients with severe EDS, treatment with solriamfetol
resulted in greater improvements in depressive symptoms compared to placebo. The study was not powered to demonstrate statistical significance in the prespecified subgroups.
Axsome plans to begin a Phase 3 trial in major depressive disorder patients with excessive daytime sleepiness in 2025.
Shares of Axsome Therapeutics are down 3% in pre-market trade on Tuesday.
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