Evaluate the percentage of participants who exhibited clinically meaningful changes on measures of excessive daytime sleepiness (EDS) in a 12-week phase 3 study.

Solriamfetol, a dopamine-norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with EDS associated with narcolepsy (75-150 mg/d) or obstructive sleep apnea (OSA; 37.5-150 mg/d). In a 12-week phase 3 study, solriamfetol significantly reduced self-reported EDS in participants with narcolepsy.

Baseline mean (standard deviation [SD]) ESS scores were 17.3 (3.5) in the solriamfetol 75 mg group (n=59), 17.0 (3.6) in the 150 mg group (n=55), 17.2 (2.8) in the 300 mg group (n=59), and 17.3 (2.9) for placebo (n=58). At week 12, 30.5%, 40.0%, and 49.2% of participants in the solriamfetol 75, 150, and 300 mg groups, respectively, had an ESS score ≤10, compared with 15.5% of participants receiving placebo. The percentages of participants with a ≥25% decrease from baseline in ESS score were 44.1%, 47.3%, and 62.7% in the solriamfetol 75, 150, and 300 mg groups, respectively, compared with 27.6% in the placebo group. Common treatment-emergent adverse events (TEAEs; ≥5% in the combined solriamfetol population) were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety; most TEAEs were mild or moderate in severity.

This analysis further demonstrates the clinical relevance of the effects of solriamfetol for EDS in narcolepsy. TEAEs were generally mild to moderate in severity.