0403 Efficacy of Once-nightly Sodium Oxybate (ON-SXB; FT218) for Excessive Daytime Sleepiness and Cataplexy: Post-hoc Number Needed to Treat and Effect Size Analyses From REST-ON [PDF]
Sleep, 2022 Abstract Introduction Extended-release, once-nightly sodium oxybate (ON-SXB; FT218) is under FDA review for the treatment of adults with narcolepsy. RESTORE, an ongoing, open-label extension/switch study (NCT04451668), evaluates long-term ON-SXB safety and tolerability.
Michael J. Thorpy +5 more
+4 more sources
Once nightly sustained release theophylline in elderly subjects [letter] [PDF]
British Journal of Clinical Pharmacology, 1988 Andrew N. J. Rodgers +2 more
+9 more sources
Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial [PDF]
Clinical TherapeuticsIndividuals with narcolepsy are more likely to be obese than the general population. Changes in weight-related measures with extended-release, once-nightly sodium oxybate (ON-SXB) and characteristics of participants with ≥5% weight loss were assessed in a Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium ...
Thomas Roth +5 more
openalex +3 more sources
501 Clinical PK of XW10172 for Once Nightly Therapy in Patients with Narcolepsy or Sleep Disorders in Neurodegenerative Diseases [PDF]
Sleep, 2021 Abstract Introduction Patients with narcolepsy and patients with sleep disorders secondary to neurodegenerative diseases have been shown to respond to oxybate. To overcome the limitations of current oxybate therapies, we designed XW10172, a new chemical entity and GABA-B agonist with no sodium or ...
Daniel M. Canafax +2 more
openalex +2 more sources
0579 Long-Term Safety of Once-Nightly Oxybate for Narcolepsy: RESTORE Study Interim Analysis of Data [PDF]
SLEEP, 2023 Abstract Introduction The pivotal phase 3 REST-ON trial (NCT02720744) evaluated the efficacy and safety of once-nightly sodium oxybate (ON-SXB; FT218), an investigational extended-release formulation for treatment of adults with narcolepsy. In REST-ON, ON-SXB met its 3 coprimary endpoints: improvement
Thomas Stern +7 more
openalex +2 more sources
Once-nightly sodium oxybate (FT218) in the treatment of narcolepsy: a letter to the editor commenting on the recent publication by C. Kushida et al. [PDF]
Sleep, 2022 Skobieranda F, Candler S, Macfadden W.
europepmc +3 more sources
Response to: Once-nightly sodium oxybate (FT218) in the treatment of narcolepsy: a letter to the editor commenting on the recent publication by C. Kushida et al. [PDF]
Sleep, 2022 Kushida CA +7 more
europepmc +3 more sources
0836 Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy [PDF]
SLEEPAbstract Introduction Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) demonstrated efficacy in treating narcolepsy symptoms, including disrupted nighttime sleep (DNS), in the phase 3 REST-ON trial (NCT02720744). This post hoc analysis assessed ON-SXB efficacy on DNS across various participant subgroups.
Yves Dauvilliers +7 more
openalex +2 more sources
Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial [PDF]
Sleep, 2023 Yves Dauvilliers +2 more
exaly +2 more sources
Efficacy of Once-Nightly Sodium Oxybate in Patients with Narcolepsy: Post Hoc Analyses of Sensitivity, Effect Size, and Numbers Needed to Treat from the Phase 3 REST-ON Trial. [PDF]
CNS DrugsRoth T +3 more
europepmc +3 more sources