Efficacy of Once-Nightly Sodium Oxybate (ON-SXB; FT218) Across Stimulant Use Subgroups: Post-hoc Analyses From the REST-ON Trial
Recommended Citation
Thorpy M, Dauvilliers Y, Roth T, Morse AM, Roy A, Bogan R, Seiden D, Dubow J, Gudeman J. Efficacy of Once-Nightly Sodium Oxybate (ON-SXB; FT218) Across Stimulant Use Subgroups: Post-hoc Analyses From the REST-ON Trial. Sleep Med 2022; 100:S157.
Document Type
Conference Proceeding
Publication Date
12-1-2022
Publication Title
Sleep Med
Abstract
Introduction: In REST-ON (NCT02720744), once-nightly sodium oxybate (ON-SXB; FT218) resulted in significant improvement vs placebo for the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness test (MWT), Clinical Global Impression of Improvement (CGI-I) rating, and number of weekly cataplexy attacks (NCA) overall (P<0.001) and in subgroups based on concomitant stimulant use for MWT and CGI-I (all P<0.05). Post-hoc analyses to investigate ON-SXB efficacy on the secondary REST-ON endpoints of disturbed nocturnal sleep (DNS) and the Epworth Sleepiness Scale (ESS) score were similarly conducted. Materials and Methods: Individuals aged ≥16 years with narcolepsy type 1 or 2 were randomized 1:1 to receive ON-SXB (1 week, 4.5 g; 2 weeks, 6 g; 5 weeks, 7.5 g; 5 weeks, 9 g) or placebo. P values for change from baseline vs placebo at weeks 3 (6 g), 8 (7.5 g), and 13 (9 g) in ESS score, sleep shifts (ie, the number of shifts from stages N1, N2, N3 and rapid eye movement [REM] sleep to Wake and from N2, N3 and REM sleep to N1), nocturnal arousals (NA), and patient-reported outcomes of sleep quality and refreshing nature of sleep on a 100-point visual analog scale were calculated using a mixed-effects model for repeated measures. Results: Of the 190 participants in the modified intent-to-treat population, 119 were taking concomitant stimulants (ON-SXB, n=66; placebo, n=53) including modafinil (ON-SXB, 21.5%; placebo, 21.0%), armodafinil (ON-SXB, 12.1%; placebo, 6.7%), amphetamine (various; ON-SXB, 10.3%; placebo, 5.7%), and methylphenidate (ON-SXB, 10.3%; placebo, 6.7%), and 71 were not taking stimulants (ON-SXB, n=31; placebo, n=40). Improvements with ON-SXB vs placebo were observed regardless of stimulant-use subgroup for ESS (stimulants: all doses, P≤0.01; no stimulants: 6 g, directional improvement; 7.5 g, P<0.01; 9 g, P<0.001), sleep shifts (stimulants: 6 g, P<0.01; 7.5 and 9 g, P<0.001; no stimulants: all doses, P<0.001), and NA (stimulants: directional improvement, 6 g; 7.5 g, P<0.01; 9 g, P=0.001; no stimulants: 6 and 7.5 g, P<0.05; 9 g, P=0.01). Improvements with ON-SXB vs placebo were also observed on the patient-reported outcomes of sleep quality (stimulants: 6 and 7.5 g, P<0.01; 9 g, P<0.05; no stimulants: all doses P<0.001) and refreshing nature of sleep (stimulants: 6 and 9 g, P<0.05; 7.5 g, P<0.001; no stimulants: 6 and 7.5 g, P<0.01; 9 g, P=0.001). Conclusions: The results of these post-hoc analyses were consistent with the previously reported statistically significant coprimary endpoint results from REST-ON. These data support the efficacy of ON-SXB for EDS and DNS in adults, as measured by objective and subjective endpoints, regardless of concurrent stimulant use. Acknowledgements: This study was funded by Avadel Pharmaceuticals.
Volume
100
First Page
S157
