Solriamfetol Demonstrates Improvement in Cognitive Function in Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea

The new data came from Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled (SHARP) study.

Solriamfetol (Sunosi, Axsome Therapeutics, Inc) met the primary endpoint of a recent study by significantly improving cognitive function in cognitively impaired patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA).

Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. The FDA approved the drug on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. The drug is available in 75 mg and 150 mg tablets.

The new data came from Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled (SHARP) study. The randomized, double-blind, trial included 59 patients with EDS associated with OSA and impaired cognitive function. The patients were all treated with solriamfetol for 2 weeks and with placebo for 2 weeks, with the treatment periods separated by 1 week of down-titration and washout.

Solriamfetol produced a statistically significant improvement in cognitive function compared to placebo as assessed by the change from baseline on the Digit Symbol Substitution Test subtest of the Repeatable Battery for the Assessment of Neuropsychological Status, which is a neuropsychological test that assesses executive function, processing speed, and attention.

Further, significant improvement in cognitive function with solriamfetol treatment was also seen using the British Columbia Cognitive Complaints Inventory (BC-CCI) overall score compared to placebo. The BC-CCI is a patient-reported test that assesses domains of memory, concentration, trouble expressing thoughts, word finding, and problem solving.

The study found that solriamfetol significantly improved EDS symptoms compared to placebo, according to a measurement from the Epworth Sleepiness Scale (ESS). The improvement on the ESS with solriamfetol treatment was approximately twice what was observed with placebo.

The most reported adverse events (AEs) with solriamfetol treatment were nausea and anxiety, with a study completion rate of 96.7% for patients randomized to each treatment sequence.

“Cognitive impairment in patients with EDS associated with OSA is extremely common and one of the most burdensome symptoms for patients,” said Richard Bogan, MD, FCCP, associate clinical professor at the University of South Carolina School of Medicine, associate clinical professor at Medical University of South Carolina, and principal of Bogan Sleep Consultants, in a press release. “The results of the SHARP study demonstrate a clinically important improvement in cognitive function with Sunosi treatment in cognitively impaired patients with EDS and OSA. Of importance, the results from the patient-reported outcomes are consistent with the objective measures, meaning that patients themselves were able to perceive improvements in their cognitive performance with Sunosi treatment. The ability to address cognitive symptoms would represent an important advancement in the treatment of EDS associated with OSA.”

REFERENCE

Axsome Therapeutics announces sunosi® (solriamfetol) meets primary endpoint demonstrating improvement in cognitive function in the sharp trial in cognitively impaired patients with excessive daytime sleepiness associated with obstructive sleep apnea. Axsome. October 3, 2022. Accessed October 7, 2022. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-sunosir-solriamfetol-meets-primary