Cargando…

The Xyrem(®) (Sodium Oxybate) Risk Evaluation and Mitigation Strategy (REMS) Program in the USA: Results From 2016 to 2017

BACKGROUND: Sodium oxybate, which is approved for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy, is available in the USA only through the restricted-distribution Xyrem(®) Risk Evaluation and Mitigation Strategy Program (Xyrem REMS Program, XRP). The XRP requi...

Descripción completa

Detalles Bibliográficos
Autores principales:	Strunc, Michael J., Black, Jed, Lillaney, Prasheel, Profant, Judi, Mills, Sherice, Bujanover, Shay, Thorpy, Michael J.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2021
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984153/ https://www.ncbi.nlm.nih.gov/pubmed/33439474 http://dx.doi.org/10.1007/s40801-020-00223-6

Ejemplares similares

Long-term Effect of Sodium Oxybate (Xyrem®) in Spasmodic Dysphonia with Vocal Tremor
por: Simonyan, Kristina, et al.
Publicado: (2013)

Individualized Treatment Patterns for Patients with Narcolepsy Treated with Oxybate: A Clinical Practice Perspective
por: Roy, Asim, et al.
Publicado: (2023)

Long-Term Treatment of Narcolepsy and Idiopathic Hypersomnia with Low-Sodium Oxybate
por: Schneider, Logan D, et al.
Publicado: (2023)

Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications
por: Dauvilliers, Yves, et al.
Publicado: (2022)

Correction to: Changes in Cataplexy Frequency in a Clinical Trial of Lower‑Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications
por: Dauvilliers, Yves, et al.
Publicado: (2022)

Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment
por: Morse, Anne Marie, et al.
Publicado: (2023)

REM Sleep Behavior Disorder in Children With Type 1 Narcolepsy Treated With Sodium Oxybate
por: Antelmi, Elena, et al.
Publicado: (2021)

Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia
por: Thorpy, Michael J, et al.
Publicado: (2022)

A proposed preventive role for Gamma-hydroxybutyrate (Xyrem(R)) in Alzheimer’s disease
por: Maitre, Michel, et al.
Publicado: (2016)

Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy
por: Bogan, Richard K, et al.
Publicado: (2020)

Corrigendum to: Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy
por: Bogan, Richard K, et al.
Publicado: (2021)

Corrigendum to: Efficacy and Safety of Calcium, Magnesium, Potassium, and Sodium Oxybates (Lower-Sodium Oxybate [LXB]; JZP-258) in a Placebo-Controlled, Double-Blind, Randomized Withdrawal Study in Adults With Narcolepsy With Cataplexy
por: Bogan, Richard K, et al.
Publicado: (2021)

Long-Term Safety and Tolerability During a Clinical Trial and Open-Label Extension of Low-Sodium Oxybate in Participants with Narcolepsy with Cataplexy
por: Bogan, Richard K., et al.
Publicado: (2023)

Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
por: Dauvilliers, Yves, et al.
Publicado: (2022)

Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients with Narcolepsy: A Commentary
por: Rosenberg, Russell, et al.
Publicado: (2023)

Sleep, Narcolepsy, and Sodium Oxybate
por: Mamelak, Mortimer
Publicado: (2022)

Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial
por: Dauvilliers, Yves, et al.
Publicado: (2023)

Sodium Oxybate: a Substitute for Alcohol?
por: Gual, A., et al.
Publicado: (2022)

Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy
por: Kushida, Clete A, et al.
Publicado: (2021)

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
por: Roth, Thomas, et al.
Publicado: (2022)

Evaluation of Quality of Life in Patients With Narcolepsy Treated With Sodium Oxybate: Use of the 36-Item Short-Form Health Survey in a Clinical Trial
por: Bogan, Richard, et al.
Publicado: (2016)

Psychosis in Patients with Narcolepsy as an Adverse Effect of Sodium Oxybate
por: Sarkanen, Tomi, et al.
Publicado: (2014)

Sodium oxybate—a new horizon for symptomatic treatment of RBD?
por: Stefani, Ambra, et al.
Publicado: (2023)

Sodium Oxybate: A Cause of Extreme Involuntary Weight Loss in a Young Lady
por: Noujaim, Michael G., et al.
Publicado: (2019)

Correlation of Changes in Patient-Reported Quality of Life With Physician-Rated Global Impression of Change in Patients With Narcolepsy Participating in a Clinical Trial of Sodium Oxybate: A Post Hoc Analysis
por: Bogan, Richard K., et al.
Publicado: (2017)

Off-label Sodium Oxybate in Childhood Narcolepsy: A Comprehensive Report
por: Miskoff, Jeffrey A, et al.
Publicado: (2018)

Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union
por: Iranzo, Alex, et al.
Publicado: (2020)

Sodium oxybate therapy provides multidimensional improvement in fibromyalgia: results of an international phase 3 trial
por: Spaeth, Michael, et al.
Publicado: (2012)

Implications of Risk Evaluation and Mitigation Strategy (REMS) Programs for Managed Care Pharmacy
por: Projects, AMCP Special
Publicado: (2012)

A Case of Off-label Sodium Oxybate in an 11-Year-Old with Narcolepsy
por: Miskoff, Jeffrey A, et al.
Publicado: (2019)

Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder
por: During, Emmanuel H, et al.
Publicado: (2023)

Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function
por: Blanchette, Christopher M, et al.
Publicado: (2015)

A Brief Up-Date of the Use of Sodium Oxybate for the Treatment of Alcohol Use Disorder
por: Caputo, Fabio, et al.
Publicado: (2016)

Increasing Evidence for the Use of Sodium Oxybate in Multi-Drug-Resistant Lance–Adams Syndrome
por: Riboldi, Giulietta M., et al.
Publicado: (2019)

Decreased body mass index during treatment with sodium oxybate in narcolepsy type 1
por: Schinkelshoek, Mink S., et al.
Publicado: (2018)

Preferences for Attributes of Sodium Oxybate Treatment: A Discrete Choice Experiment in Patients with Narcolepsy
por: Dubow, Jordan, et al.
Publicado: (2022)

Correction to: Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder
Publicado: (2023)

O024 Sodium oxybate for refractory narcolepsy and idiopathic hypersomnia: clinical and employment outcomes
por: Hernest, A, et al.
Publicado: (2023)

Local Aspects of Avian Non-REM and REM Sleep
por: Rattenborg, Niels C., et al.
Publicado: (2019)

Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia
por: Spaeth, Michael, et al.
Publicado: (2013)

Cannot write session to /tmp/vufind_sessions/sess_7e94it0ehvpokri3s7u3ptanj4