488 REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy

• Published in: Sleep (New York, N.Y.) N.Y.), 2021-05, Vol.44 (Supplement_2), p.A192-A193
• Main Authors: Thorpy, Michael, Roth, Thomas, Dauvilliers, Yves, Kushida, Clete, Shapiro, Colin, Corser, Bruce, Ajayi, Akinyemi, Dubow, Jordan, Seiden, David, Rosenberg, Russell
• Format: Article
• Language: English
• Subjects: Double-blind studies; Hallucinations; Sleep disorders
• ISSN: 0161-8105; 1550-9109
• DOI: 10.1093/sleep/zsab072.487

Introduction Sodium oxybate (SO) is an effective treatment for narcolepsy; however, currently available formulations must be taken twice nightly. FT218 is an investigational once-nightly controlled-release formulation of SO. Here, we evaluated the efficacy of FT218 on excessive daytime sleepiness (EDS), self-reported sleep quality/refreshing nature of sleep, sleep paralysis (SP), and hypnagogic hallucinations (HH) in patients with narcolepsy. Methods In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, patients aged ≥16 years with narcolepsy type 1 or 2 were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night (1 week), 6.0 g/night (2 weeks), 7.5 g/night (5 weeks), and 9.0 g/night (5 weeks). Secondary efficacy endpoints included EDS using the Epworth Sleepiness Scale (ESS), sleep quality/refreshing nature of sleep using a visual analog scale (VAS), and SP and HH using a sleep symptom diary. Results A total of 212 patients were randomized and received study medication (FT218, n=107; placebo, n=105). Patients receiving FT218 had significant improvement vs placebo in EDS on the ESS: LS mean difference on ESS score between FT218 and placebo was −3.86 for 9.0 g (week 13), −3.16 for 7.5 g (week 8), and −2.06 for 6.0 g (week 3) (all P