Axsome announces results from PARADIGM Phase 3 trial of solriamfetol

Axsome Therapeutics (AXSM) announced results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder, MDD, with and without severe excessive daytime sleepiness, EDS. In the overall patient population, the study did not demonstrate a statistically significant change on the Montgomery-Asberg Depression Rating Scale, MADRS, total score compared to placebo, the study’s 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. Based on the results in the EDS subgroup, Axsome plans to initiate a Phase 3 trial in MDD patients with EDS in 2025. The PARADIGM study was a 6-week, randomized, double-blind, placebo-controlled, multicenter, U.S. trial, in which MDD patients with severe EDS and without severe EDS were randomized to treatment with solriamfetol 300 mg or placebo. EDS was assessed using the Epworth Sleepiness Scale. In MDD patients with severe EDS, solriamfetol treatment resulted in clinically meaningful and numerically greater improvements compared to placebo on multiple efficacy measures including MADRS total score, MADRS anhedonia subscale, MADRS remission, Clinical Global Impression of Severity, Clinical Global Impression of Improvement, and Patient Global Impression of Improvement, at Week 6. In patients without severe EDS, there was no meaningful difference as compared to placebo on the study endpoints.