RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates.

Autor:	Roy A; Ohio Sleep Medicine Institute, Dublin, OH, USA., Stern T; Advanced Respiratory and Sleep Medicine, PLLC, Huntersville, NC, USA., Harsh J; Colorado Sleep Institute, Boulder, CO, USA., Hudson JD; FutureSearch Trials of Neurology, Austin, TX, USA., Ajayi AO; Florida Pediatric Research Institute, Winter Park, FL, USA., Corser BC; Sleep Management Institute, Cincinnati, OH, USA., Mignot E; Center for Narcolepsy, Stanford University, Palo Alto, CA, USA., Santamaria A; Northwest Houston Neurology & Comprehensive Sleep Medicine Center, Houston, TX, USA., Morse AM; Geisinger Commonwealth School of Medicine, Geisinger Medical Center, Janet Weis Children's Hospital, Danville, PA, USA., Abaluck B; Avadel Pharmaceuticals, Chesterfield, MO, USA., Ibrahim S; University Hospitals Cleveland Medical Center, Cleveland, OH, USA., Schweitzer PK; Sleep Medicine & Research Center, St. Luke's Hospital, Chesterfield, MO, USA., Lancaster K; Patient Author, USA., Dubow J; Avadel Pharmaceuticals, Chesterfield, MO, USA., Gudeman J; Avadel Pharmaceuticals, Chesterfield, MO, USA.
Jazyk:	angličtina
Zdroj:	Sleep medicine: X [Sleep Med X] 2024 Aug 15; Vol. 8, pp. 100122. Date of Electronic Publication: 2024 Aug 15 (Print Publication: 2024).
DOI:	10.1016/j.sleepx.2024.100122
Abstrakt:	Objective/background: Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE (NCT04451668). Patients/methods: Participants aged ≥16 years with narcolepsy who completed the phase 3 REST-ON trial, were oxybate-naive, or were on a stable IR oxybate dose (≥1 month) were eligible for RESTORE. For participants who switched from twice-nightly dosing to ON-SXB, initial doses were closest or equivalent to their previous nightly IR oxybate dose. These participants completed a questionnaire at baseline about nocturnal adverse events associated with the middle-of-the-night IR oxybate dose in the preceding 3 months, a preference questionnaire after 3 months of stable-dose ON-SXB, and an end-of-study (EOS) questionnaire. Results: There were 130 switch participants; 92/98 (93.9 %) who completed the preference questionnaire preferred ON-SXB. At baseline, 69.2 % reported missing their second IR oxybate dose at least once; in these cases, 80 % felt worse the next day. Approximately 39 % reported taking a second nightly IR oxybate dose >4 h after the first dose, 51 % of whom felt somewhat to extremely groggy/unsteady the next morning; 120 participants (92 %) reported getting out of bed after their second oxybate dose. Of those, 9 (8 %) reported falls and 5 (4 %) reported injuries. Of the switch participants who completed the EOS questionnaire, 91.2 % felt better able to follow the recommended ON-SXB dosing schedule. Conclusions: The second nightly IR oxybate dose presents significant treatment burdens and adherence concerns. Participants overwhelmingly preferred the once-nightly dosing regimen of ON-SXB. Competing Interests: AR has received grant/research support from Jazz Pharmaceuticals, Suven, Inspire, Nyxoah, LivaNova, and Avadel Pharmaceuticals; is a speaker for Avadel Pharmaceuticals; is a consultant for Jazz Pharmaceuticals, Suven, Inspire, and Avadel Pharmaceuticals; and has served on speakers bureaus for Jazz Pharmaceuticals and Eisai. TS is a consultant and speaker for Avadel Pharmaceuticals. JH has nothing to disclose. JDH has nothing to disclose. AOA is a consultant and speaker for Avadel Pharmaceuticals. BCC is a member of the speakers bureaus of Jazz Pharmaceuticals; Merck & Co., Inc.; Eisai; and Harmony Biosciences. He is an advisor for and has received consulting fees and honoraria from Avadel Pharmaceuticals. EM has received clinical trial or research funding from Apple, Avadel Pharmaceuticals, Eisai, Jazz Pharmaceuticals, Suven, and Takeda; owns stocks in Centessa and Sleep Apnea Co; and has consulted for or received honorarium from Avadel Pharmaceuticals, Idorsia, Jazz Pharmaceuticals, and Takeda. AS has received research grants from Avadel Pharmaceuticals and Harmony Biosciences and has served on speakers bureaus for Avadel Pharmaceuticals, Jazz Pharmaceuticals, and Axsome Pharmaceuticals. AMM has served as a consultant, speaker, and/or on advisory boards for Avadel Pharmaceuticals, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Alkermes, and Takeda Pharmaceutical Co; has received grant funding from National Institutes of Health, UCB Pharmaceuticals, Jazz Pharmaceuticals, ResMed Foundation, Coverys Foundation, and Geisinger Health Plan; is the CEO of DAMM Good Sleep, LLC; and has served as an advisor for Neura Health. BA is an employee of Avadel Pharmaceuticals. SI is affiliated with a hospital that received funding for the RESTORE trial and has received clinical trial research funding from Jazz Pharmaceuticals, Harmony Biosciences, and the National Institutes of Health. PKS received payment from Apnimed Inc., as a consultant. Her institution has received research funding from Apnimed Inc., Avadel, Harmony Biosciences, Inspire Medical, and Jazz Pharmaceuticals. KL was enrolled as a study participant in the RESTORE study. Following her participation in RESTORE, KL has received compensation from Avadel for speaking activities related to sharing her experience as a person with narcolepsy and with ON-SXB. JD was an employee of Avadel Pharmaceuticals at the time of the trial. JG is an employee of Avadel Pharmaceuticals. (© 2024 The Authors.)
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