Results 11 to 20 of about 2,529,164 (287)

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 Drugs
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 dose) and 2 (6-g dose).
Krahn L, Roy A, Winkelman JW, Morse AM, Gudeman J.   +4 more
europepmc   +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 Drugs
Once-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, Thorpy MJ, Kushida CA, Gudeman J.   +3 more
europepmc   +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
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, Roth T, Bogan R, Thorpy MJ, Morse AM, Roy A, Dubow J, Gudeman J.   +7 more
europepmc   +2 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
Abstract Introduction Sodium oxybate is an effective treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy. The approved formulation requires twice-nightly dosing: at bedtime and 2.5 - 4 hours later, which results in two distinct Cmax’s.
Kushida CA, Roth T, Shapiro CM, Roy A, Rosenberg R, Ajayi AO, Seiden D, Gudeman J.   +7 more
europepmc   +3 more sources

KeYProject/key: Nightly Release

<p><!-- Release notes generated using configuration in .github/release.yml at nightly --></p> <p><strong>Full Changelog</strong>: https://github.com/KeYProject/key/compare/KeY-2.4.0...nightly</p ...
mi.ki, Tobias Reinhold, SeeVella, Florian Lanzinger, David Giessing, T. Lippert, PumpkinPieTroelf, simongreiner, Daniel Drodt, Carsten Csiky, rheimbach, Wolfram Pfeifer, jwiesler, vladrich, Wojciech Mostowski, zhao-nan, Alexander Weigl, Moritz v. Looz, unp1, Mattias Ulbrich, pschmitt27, alicia, danielgrahl, Arne Keller, lichtemo, Lukas Grätz, Jonas Krämer, Christopher Beckmann   +27 more
core   +15 more sources

Practical Guidance for Initiation and Management of Patients on Once-Nightly Sodium Oxybate for Narcolepsy Treatment: Modified Delphi Panel Consensus Recommendations [PDF]

Neurology and Therapy
Introduction Despite its strong recommendation for treatment of excessive daytime sleepiness (EDS), cataplexy, and disease severity associated with narcolepsy by the American Academy of Sleep Medicine, sodium oxybate (SXB) remains underutilized.
Monique Mulvany, Ellen Wermter, Maggie Lavender, Heidy Merius, Cecile Martin, Amber Burns, Jamie Simmons   +6 more
doaj   +2 more sources

Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. [PDF]

CNS Drugs, 2022
Sodium oxybate has been recognized as a gold standard for the treatment of disrupted nighttime sleep due to narcolepsy. Its short half-life and immediate-release formulation require patients to awaken 2.5–4 h after their bedtime dose to take a second ...
Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D.   +8 more
europepmc   +2 more sources

Dissolution of Once-Nightly Sodium Oxybate in Soft Foods and Alternative Liquid Reconstitution Vehicles

Clinical Therapeutics
Narcolepsy is a chronic neurologic disorder characterized by excessive daytime sleepiness (EDS) and can occur with or without cataplexy. Once-nightly sodium oxybate (ON-SXB) is approved for the treatment of cataplexy or EDS in patients 7 years of age or older with narcolepsy.
Maggie, Lavender, Anne Marie, Morse, Bahador Mark, Tafazoli, Feri, Ascencion, Ellen, Wermter, Laura B, Herpel, Jennifer, Gudeman, William John, Schaefer, Jason, Vaughn   +8 more
openaire   +3 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

Clinical Therapeutics
Individuals 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 ...
Roth, Thomas, Morse, Anne Marie, Bogan, Richard, Roy, Asim, Gudeman, Jennifer, Dauvilliers, Yves   +5 more
openaire   +3 more sources

Randomized, crossover, open-label study of the relative bioavailability and safety of FT218, a once-nightly sodium oxybate formulation: Phase 1 study in healthy volunteers

Sleep Medicine, 2022
OBJECTIVES Treatment for narcolepsy with sodium oxybate (SXB) has required twice-nightly dosing, at bedtime and 2.5-4 h later. This study evaluated the pharmacokinetics of FT218, an investigational, extended-release, once-nightly formulation of SXB (ON ...
Richard Bogan, David Seiden, Jennifer Gudeman   +2 more
exaly   +2 more sources