Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial
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DOI: 10.1007/s40263-024-01143-7
Abstract: Once-nightly sodium oxybate (LUMRYZ™; ON-SXB; FT218) significantly improved narcolepsy symptoms in the phase 3 REST-ON trial. The objective of this post hoc analysis was to investigate the early efficacy of ON-SXB at weeks 1 (4.5-g… read more here.
Keywords: hoc analysis; sleep quality; efficacy; sxb ... See more keywords
Once-Nightly Sodium Oxybate (FT218) Demonstrated Improvement of Symptoms in a Phase 3 Randomized Clinical Trial in Patients With Narcolepsy.
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DOI: 10.1093/sleep/zsab200
Abstract: STUDY OBJECTIVES To assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial. METHODS Narcolepsy patients aged ≥16 years were… read more here.
Keywords: improvement; sxb; ft218; sodium oxybate ... See more keywords
0579 Long-Term Safety of Once-Nightly Oxybate for Narcolepsy: RESTORE Study Interim Analysis of Data
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DOI: 10.1093/sleep/zsad077.0579
Abstract: 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… read more here.
Keywords: safety; oxybate; sxb; restore study ... See more keywords
Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder.
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DOI: 10.1093/sleep/zsad103
Abstract: STUDY OBJECTIVES Symptomatic therapies for REM sleep behavior disorder (RBD) are limited. Sodium oxybate (SXB), a gamma-aminobutyric acid (GABA)-B agonist, could be effective but has not been evaluated against placebo. METHODS This double-blind, parallel-group, randomized,… read more here.
Keywords: sleep behavior; rbd; behavior disorder; rem sleep ... See more keywords
Effects of sodium oxybate on hypocretin/orexin and locus coeruleus neurons.
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DOI: 10.1093/sleep/zsad135
Abstract: Longterm use of sodium oxybate (SXB), (also called gamma-hydroxybutyrate (GHB)) attenuates the cataplexy and sleepiness of human narcolepsy. We had previously found that chronic opiate usage in humans and longterm opiate administration to mice significantly… read more here.
Keywords: sodium oxybate; hypocretin orexin; locus coeruleus; sxb ... See more keywords
0835 Improvement of Individual Excessive Daytime Sleepiness Symptoms with Once-Nightly Sodium Oxybate for Narcolepsy
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DOI: 10.1093/sleep/zsaf090.0835
Abstract: The Epworth Sleepiness Scale (ESS) is a commonly used 8-item patient-reported outcome measure for excessive daytime sleepiness. While aggregate data are typically presented, individual domains vary in clinical significance. This post hoc analysis from the… read more here.
Keywords: improvement; daytime sleepiness; excessive daytime; sxb ... See more keywords
0836 Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy
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DOI: 10.1093/sleep/zsaf090.0836
Abstract: 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… read more here.
Keywords: week; efficacy; sxb; sxb placebo ... See more keywords
0857 REFRESH: Prospective, Observational Study Design of Once-Nightly Sodium Oxybate for Narcolepsy in Clinical Practice
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DOI: 10.1093/sleep/zsaf090.0857
Abstract: Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is approved to treat excessive daytime sleepiness and cataplexy in adult and pediatric patients ≥7 years of age with narcolepsy. The REFRESH study assesses the clinical effectiveness, patient satisfaction, and… read more here.
Keywords: observational study; sodium oxybate; sxb; narcolepsy ... See more keywords