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Abstract Introduction Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is an effective and safe treatment for excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. This post hoc analysis assessed efficacy in female and male participant subgroups from the phase 3 REST-ON trial. Methods REST-ON (NCT02720744) participants (≥16 years) with narcolepsy type 1 (NT1) or NT2 were randomized (1:1) to receive ON-SXB at 4.5 g (week 1), 6 g (weeks 2–3), 7.5 g (weeks 4–8), and 9 g (weeks 9–13) or placebo. Data shown are least squares mean changes from baseline (SE) in mean sleep latency on the Maintenance of Wakefulness Test (MWT) and weekly number of cataplexy episodes (NCA; NT1 only) calculated at week 13 (9 g) in the modified intent-to-treat (mITT) population (ie, randomized participants with ≥1 efficacy measurement post 6-g dose). Results The mITT population included more female (ON-SXB, n=60; placebo, n=65) than male (ON-SXB, n=37; placebo, n=28) participants. Baseline mean sleep latency (SD) on the MWT (min) was 5.24 (3.41) and 4.59 (2.65) for female and male participants in the ON-SXB arm, respectively. At week 13, improvements on the MWT with ON-SXB were greater for female than for male participants (11.62 1.39, 9.52 1.26). Baseline mean weekly NCA (SD) was 19.63 (9.0) and 17.48 (8.03) for female and male participants, respectively, in the ON-SXB arm. Improvements in weekly NCA with ON-SXB were similar for female and male participants at week 13 (–11.80 1.23, –11.31 1.62). Conclusion These post-hoc subgroup data demonstrate improvement with ON-SXB in EDS and in cataplexy for people with narcolepsy regardless of gender. Support (if any) Avadel Pharmaceuticals
Thorpy et al. (Sat,) studied this question.