Axsome to battle on with solriamfetol despite mixed data

CNS specialist Axsome Therapeutics (Nasdaq: AXSM) has announced results from the PARADIGM Phase III 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-Åsberg depression rating scale (MADRS) total score compared to placebo, the study’s primary endpoint.

In the prespecified subgroup of patients with severe EDS, however, treatment with solriamfetol did result in greater improvements in depressive symptoms compared to placebo.