Axsome Therapeutics Inc's (NASDAQ: AXSM) Sunosi met the primary endpoint in the SHARP study and significantly improved cognitive function compared to placebo in patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).
Sunosi demonstrated statistically significant improvement in cognitive function compared to placebo as assessed by the change from baseline on the DSST RBANS (6.49 vs. 4.75), with an effect size of 0.36.
The DSST RBANS is an objective neuropsychological test that assesses executive function, processing speed, and attention.
Statistically significant improvement in cognitive function with Sunosi treatment was also demonstrated using the British Columbia Cognitive Complaints Inventory (BC-CCI) overall score compared to placebo, with an effect size of 0.43.
The BC-CCI is a patient-reported test that assesses domains of memory, concentration, trouble expressing thoughts, word finding, and problem-solving.
The improvement in the ESS with Sunosi treatment was approximately twice that observed with placebo, with an effect size of 0.50.
The most commonly reported adverse events with Sunosi treatment were nausea (6.9%) and anxiety (3.4%).
The company said that the mechanism of action of solriamfetol to improve wakefulness in patients with EDS associated with narcolepsy or OSA and to potentially affect cognition, is unclear.
Price Action: AXSM shares are up 4.21% at $46.50 during the premarket session on the last check Monday.
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