0406 Efficacy of Once-Nightly Sodium Oxybate (ON-SXB; FT218) Across Stimulant Use Subgroups: Post-hoc Analyses From the REST-ON Trial

Abstract Introduction In the REST-ON trial (NCT02720744), once-nightly sodium oxybate (ON-SXB; FT218) was associated with significant improvement vs placebo for mean sleep latency on Maintenance of Wakefulness test (MWT) and Clinical Global Impression Improvement (CGI-I) rating in overall population (both P<0.001) subgroups participants taking concomitant stimulants P<0.05). Post-hoc analyses ON-SXB efficacy disturbed nocturnal (DNS) Epworth Sleepiness Scale (ESS) score were conducted. Methods Participants (≥16 years age) narcolepsy type 1 or 2 randomized 1:1 to (1 week, 4.5 g; weeks, 6 5 7.5 9 g) placebo. Mixed-effects models repeated measures calculated P values change from baseline at weeks 3 (6 g), 8 (7.5 13 (9 ESS score, shifts (ie, number N1, N2, N3, rapid eye movement [REM] Wake REM N1), arousals (NA), patient-reported outcomes quality refreshing nature a 100-point visual analog scale. Results modified intent-to-treat (n=190), 119 took (ON-SXB, n=66; placebo, n=53); 71 did not take n=31; n=40). Improvements reported: (stimulants: all doses, P≤0.01; no stimulants: g, directional improvement; P<0.01; P<0.001), P<0.001; doses NA P=0.001; P<0.05; P=0.01), P=0.001). Conclusion Data these post-hoc consistent previously reported results support EDS DNS, as measured by objective subjective endpoints whether concurrently used. Support (If Any) Avadel Pharmaceuticals