Axsome Reports (SHARP) Study Results of Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea

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The (SHARP) study evaluates Sunosi vs PBO in a ratio (1:1) in 59 patients with EDS associated with OSA and impaired cognitive function for 2wks.
The trial met its 1EPs i.e., improvement in cognitive function as measured by DSST RBANS, significant patient-reported improvement in cognitive function as measured by the BC-CC, and reduction in EDS symptoms. The company plans to discuss the results with the US FDA shortly
In new preclinical pharmacology studies, Solriamfetol activates human TAAR1 in vitro at potencies that overlap with observed dopamine and norepinephrine transporter inhibitory potencies and are within the clinically relevant plasma concentration range; no human TAAR1 activity was seen

Ref: GlobeNewswire | Image: Axsome