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 Study Objectives Post hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1) and 2 (NT2 ...
Dauvilliers Y +7 more
europepmc +4 more sources
RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates [PDF]
Sleep Medicine: XObjective/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 ...
Asim Roy +14 more
doaj +4 more sources
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
semanticscholar +5 more sources
SLEEP, 2023 Abstract Introduction Once-nightly sodium oxybate (ON-SXB; FT218), an investigational, extended-release treatment, was evaluated for the treatment of narcolepsy in adults in the phase 3 REST-ON clinical trial (NCT02720744).
Thomas Roth +6 more
semanticscholar +4 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 DrugsOnce-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved 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 ...
Roth T +3 more
europepmc +2 more sources
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. [PDF]
CNS DrugsOnce-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 dose) and 2 (6-g dose).
Krahn L +4 more
europepmc +2 more sources
Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients with Narcolepsy: A Commentary [PDF]
Neurology and Therapy, 2023 Narcolepsy is associated with disrupted nighttime sleep (DNS). Sodium oxybate (SXB; Xyrem®), administered twice nightly, is indicated for the treatment of cataplexy and excessive daytime sleepiness in patients 7 years or older with narcolepsy.
Russell Rosenberg +5 more
doaj +2 more sources
Individualized Treatment Patterns for Patients with Narcolepsy Treated with Oxybate: A Clinical Practice Perspective [PDF]
Nature and Science of Sleep, 2023 Asim Roy,1 Diane Ito,2 Susan Morris,3 Shawn Candler,4 Judi Profant,3 Charles Bae5 1Ohio Sleep Medicine Institute, Dublin, OH, USA; 2Stratevi LLC, Santa Monica, CA, USA; 3Jazz Pharmaceuticals, Palo Alto, CA, USA; 4Jazz Pharmaceuticals, Philadelphia, PA ...
Roy A +5 more
doaj +2 more sources
0589 Dose Titration of Once-Nightly Sodium Oxybate: Analysis of Interim Data From RESTORE
SLEEP, 2023 Abstract Introduction FT218 (LUMRYZ™) is an investigational once-nightly sodium oxybate (ON-SXB) for treatment of adults with narcolepsy type 1 (NT1) or type 2 (NT2). The efficacy and safety of ON-SXB at doses 6, 7.5, and 9 g in patients with NT1/NT2 were confirmed in the phase 3 REST-ON clinical ...
Asim Roy +5 more
openaire +2 more sources
Evidence of Accidental Dosing Errors with Immediate-Release Sodium Oxybate: Data from the US Food and Drug Administration Adverse Event Reporting System [PDF]
Drugs - Real World Outcomes, 2023 Introduction Sodium oxybate has been approved by the US Food and Drug Administration (FDA) to treat narcolepsy for 20 years; however, the only available products have been immediate-release (IR) formulations given twice nightly—once at bedtime and a ...
Jennifer Gudeman, Danielle Burroughs
doaj +2 more sources