P003 Randomised, placebo-controlled study of solriamfetol for excessive daytime sleepiness in narcolepsy types 1/2

Introduction Solriamfetol (formerly JZP-110), a dopamine and norepinephrine reuptake inhibitor, has been approved in the United States to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75–150 mg) or obstructive sleep apnoea (OSA; 37.5–150 mg). A Marketing Authorisation Application for these indications is under review with the European Medicines Agency. This phase 3 study assessed safety and efficacy of solriamfetol in participants with narcolepsy types 1 and 2 (NT1/2).1 Methods In this 12-week, double-blind, randomised, placebo-controlled study, participants with or without cataplexy were randomised to solriamfetol 75 mg, 150 mg, 300 mg, or placebo. Eligibility criteria: NT1/2 diagnosis; mean sleep latency Results 236 participants received ≥1 dose of solriamfetol (67.2% female; 80.2% white). Baseline MWT mean sleep latency: 7.5 minutes; baseline ESS score: 17.2. Solriamfetol significantly increased MWT sleep latency at week 12 (P Discussion Solriamfetol improved wakefulness and reduced EDS in participants with NT1/2. Most AEs were mild to moderate. Support Jazz Pharmaceuticals. Reference Thorpy MJ, et al. Ann Neurol 2019;85(3):359–370.