0607 Improvement in Sleep Latency With FT218 (Once-Nightly Sodium Oxybate): Analysis From the Phase 3 REST-ON Clinical Trial

Abstract Introduction In the phase 3 REST-ON trial (NCT02720744), mean sleep latency on Maintenance of Wakefulness Test (MWT) was significantly improved vs placebo with investigational, extended-release once-nightly sodium oxybate (FT218 [ON-SXB]; P< 0.001). This post hoc analysis assessed response to treatment and improvement in excessive daytime sleepiness (EDS). Methods Participants (≥16 years) narcolepsy type 1/2 were randomized 1:1 double-blind ON-SXB or placebo. Doses 4.5 g week 1, 6 weeks 2‒3, 7.5 4‒8, 9 9‒13. Mean MWT measured 5 trials up 30 minutes each at baseline 3, 8, 13. Percentage participants ≥5, ≥10, ≥15, ≥20 from latency=30 assessed. Two-sided P values calculated using Fisher exact test. Results The modified intent-to-treat population included 190 (ON-SXB, n=97; placebo, n=93). At baseline, (SD) as follows: ON-SXB, 5.0 (3.1) minutes; 4.7 (2.6) minutes. More receiving had MWT=30 (6 g; 5.7% 0%; 0.05), 8 (7.5 10.5% 1.3%; 13 (9 13.2% 5.1%; P=0.14). A greater percentage ≥5 over all doses g: min, 57.5% 25.0%; ≥10 35.6% 9.1%; ≥15 18.4% 3.4%; 10.3% 1.1% [all 0.01]; 7.5g: 63.2% 28.2%; 43.4% 11.5%; 31.6% 3.8%; 15.8% 1.3% 0.001]; 66.2% 37.2% [P< 50.0% 19.2% 32.4% 17.6% 6.4% 0.05]). Conclusion Clinically significant improvements EDS occurred 6-, 7.5-, 9-g ON-SXB. 2 highest doses, >10% remained awake for entire MWT. If is granted FDA approval, adults will have a improve EDS. Support (if any) Avadel Pharmaceuticals