Axsome Therapeutics is announcing new data from the SHARP study, a trial of Sunosi (solriamfetol) in 59 patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea and impaired cognitive function, from which positive topline results were announced in October 2022.

The new data from the SHARP (Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled) study is being presented at the 2023 American Academy of Neurology Annual Meeting, held from April 22 to 27 in Boston, and includes detailed secondary endpoints for the British Columbia Cognitive Complaints Inventory and the Epworth Sleepiness Scale.

“The SHARP study is exciting because it overcomes treatment barriers associated with the complex relationship between cognitive impairment and OSA,” says Hans Van Dongen, PhD, Professor at Washington State University and first author of the SHARP study abstract, in a press release. “Endpoints from the SHARP study show potential clinical benefit for patients taking solriamfetol versus placebo, suggesting it can be a robust option for the treatment of patients with EDS due to OSA. These new data, and other studies being shared at AAN, support the notion that solriamfetol performs according to label specifications and has potential to make a meaningful difference for patients with OSA and excessive daytime sleepiness.”

Additional presentations at the American Academy of Neurology conference highlight data on the TAAR1 agonist mechanism of action of solriamfetol and data from the ongoing SURWEY real-world experience study of Sunosi. SURWEY is a retrospective chart review among physicians in Germany prescribing solriamfetol for patients with EDS associated with narcolepsy or OSA. 

Sunosi received US Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a schedule IV medicine by the US Drug Enforcement Agency on June 17, 2019.