AXSM - Axsome gains as sleep disorder therapy increases cognitive function

Axsome Therapeutics ( NASDAQ: AXSM ) added ~7% pre-market Monday after the company announced its FDA-approved therapy for excessive daytime sleepiness (EDS) Sunosi improved the cognitive function of patients in a placebo-controlled study.

The dopamine and norepinephrine reuptake inhibitor, also known as solriamfetol, is indicated in the U.S. for adults with EDS associated with narcolepsy or obstructive sleep apnea (OSA).

The SHARP trial enrolled 59 patients with EDS and OSA who had impaired cognitive function. They underwent Sunosi treatment for two weeks and received the placebo for another two weeks after a one-week duration.

The trial met the main goal as Sunosi outperformed the placebo with statistical significance in terms of the change from baseline in the DSST RBANS, a neuropsychological test (p=0.009).

There was also a statistically significant improvement compared to placebo per the British Columbia Cognitive Complaints Inventory (BC-CCI) overall score, a patient-reported cognitive function test.

The trial also confirmed previous data indicating the effect of Sunosi in significantly reducing EDS symptoms, AXSM said, citing a nearly twofold improvement of the Epworth Sleepiness Scale (ESS) in Sunosi-treated patients compared to placebo (p=0.004).

The trial indicated a completion rate of ~97%, with nausea and anxiety, cited as the most common adverse events for Sunosi. The company plans to share the data with the FDA as early as possible.

Read: The FDA approval of AXSM’s depression therapy Auvelity sent the company shares sharply higher in August.

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