Abstract
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<0.001). Sleep quality/refreshing nature of sleep on VAS was also significantly improved with FT218 vs placebo (P<0.001 for all doses). Patients receiving FT218 reported less SP vs placebo (P<0.05 at all doses). Baseline values for HH were low in both treatment groups; HH was similar for both treatment groups at all study visits. The most common adverse reactions were nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.
Conclusion
At all evaluated doses, treatment with FT218 significantly improved EDS, sleep quality/refreshing nature of sleep, and SP vs placebo. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects.
Support (if any)
Avadel Pharmaceuticals.
Association of Sleep paralysis with Insomnia and Sleep Quality