Axsome Says Sunosi Met Primary Endpoint In SHARP Study

(RTTNews) - Biopharmaceutical company Axsome Therapeutics, Inc. (AXSM) announced Monday that Sunosi met the primary endpoint in the SHARP study and significantly improved cognitive function, measured using the Digit Symbol Substitution Test subtest of the Repeatable Battery for the Assessment of Neuropsychological Status (DSST RBANS), as compared to placebo in cognitively impaired patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).

Superiority of Sunosi as compared to placebo was further demonstrated using patient-reported measures of cognitive function. In the study, Sunosi replicated previous findings by significantly reducing EDS symptoms as compared to placebo.

SHARP (Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study) was a randomized, double-blind, placebo-controlled, crossover, multicenter, trial in 59 patients with EDS associated with OSA, and impaired cognitive function.

Patients were all treated with Sunosi for 2 weeks, and with placebo for 2 weeks, with the treatment periods separated by 1 week of down-titration and washout.