490 Efficacy of FT218 on Polysomnographic Measures of Sleep Continuity in Patients With Narcolepsy: Results From the REST-ON Trial. (3rd May 2021)

• Record Type: Journal Article
• Authors: Dauvilliers, Yves; Thorpy, Michael; Roth, Thomas; Rosenberg, Russell; Corser, Bruce; Shapiro, Colin; Ajayi, Akinyemi; Dubow, Jordan; Seiden, David; Kushida, Clete
• Is Part Of: Sleep. Volume 44(2021)Supplement 2
• Page Start: A193
• Page End: A194
• Publication Date: 2021-05-03
• Subjects: Sleep -- Physiological aspects -- Periodicals; Sleep disorders -- Periodicals; Sommeil -- Aspect physiologique -- Périodiques; Sommeil, Troubles du -- Périodiques; Sleep disorders; Sleep -- Physiological aspects; Sleep -- physiological aspects; Sleep Wake Disorders; Psychophysiology; Electronic journals; Periodicals; 616.8498
• DOI: 10.1093/sleep/zsab072.489
• Languages: English
• ISSNs: 0161-8105

Abstract

Abstract: Introduction: Disturbed nocturnal sleep (DNS) is a common symptom in patients with narcolepsy, characterized by fragmented sleep, including frequent brief nightly awakenings. 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 polysomnographic (PSG) measures of DNS and number of arousals (NAs) in patients with narcolepsy types 1 and 2. Methods: This was a randomized, double-blind, placebo-controlled, multicenter study. Patients with narcolepsy aged ≥16 years were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks. Secondary endpoints included PSG measurements of DNS (defined as shifts to wake/N1 from N1, N2, N3, and REM) and NAs (defined per AASM Scoring Manual guidelines [v2.6]). Results: Patients receiving FT218 had significant improvements vs placebo in DNS; the LS mean difference between FT218 and placebo was −22.63 for 9.0 g (week 13), −17.70 for 7.5 g (week 8), and −11.00 for 6.0 g (week 3) (all P<0.001). Patients receiving FT218 also had significant reduction in number of NAs vs placebo; the LS mean difference between FT218 and placebo for NAs was −23.68 (P<0.001) for 9.0 g, −19.41 (P<0.001) for 7.5 g, and −11.29 (P=0.021) for 6.0 g. The most common adverse reactions were nausea, dizziness, enuresis, headache, decreased appetite, and vomiting. Conclusion: FT218 at all evaluated doses showed significant reduction in DNS and number of NAs vs placebo for all doses of FT218 evaluated. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects. FT218 could offer a new once-nightly treatment option for DNS in patients with narcolepsy as demonstrated by PSG measures. Support (if any): Avadel Pharmaceuticals.