Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

The Xyrem risk management program.

David E Fuller1, Carl S Hornfeldt, Judy S Kelloway

  • 1Orphan Medical Inc., Minnetonka, Minnesota 55305, USA.

Drug Safety
|April 6, 2004
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Real-World Evaluation of an EHR-Enabled Chronic Obstructive Pulmonary Disease Assessment Test.

International journal of chronic obstructive pulmonary disease·2025
Same author

Validated Assessment Scales for the Female Asian Calf.

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]·2019
Same author

A Validated Assessment Scale for Asian Chin Projection.

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]·2019
Same author

Validation of a Photonumeric Assessment Scale for Grading the Slope of the Asian Forehead.

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]·2019
Same author

Durability, Behavior, and Tolerability of 5 Hyaluronidase Products.

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]·2018
Same author

Growing evidence of the beneficial effects of a marine protein-based dietary supplement for treating hair loss.

Journal of cosmetic dermatology·2017

Sodium oxybate (GHB) is a valuable therapeutic agent approved for narcolepsy treatment. Strict risk management programs ensure its safe use, balancing medical benefits with abuse potential concerns.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Drug Abuse Research

Background:

  • Sodium oxybate, or gamma-hydroxybutyric acid (GHB), has a dual history as a therapeutic agent and a substance of abuse.
  • Its endogenous presence in the CNS suggests potential neurotransmitter functions.
  • Approved uses include anesthesia, alcohol withdrawal, and narcolepsy-related cataplexy.

Purpose of the Study:

  • To review the therapeutic applications and challenges associated with sodium oxybate (GHB).
  • To detail the regulatory and risk management strategies implemented for sodium oxybate's clinical use.
  • To highlight the development of the Xyrem Risk Management Program for safe distribution and patient compliance.

Main Methods:

  • Literature review of sodium oxybate's history, pharmacology, and clinical applications.

Related Experiment Videos

  • Analysis of regulatory actions and the development of risk management programs in the US.
  • Examination of the components and objectives of the Xyrem Success Program.

    • Main Results:

    • Sodium oxybate (GHB) has diverse medical uses but also a history of abuse and illicit applications.
    • Regulatory hurdles were overcome through legislative action and the creation of the Xyrem Risk Management Program.
    • The bifurcated scheduling under the US Controlled Substances Act allowed FDA approval for narcolepsy treatment.

    Conclusions:

    • The Xyrem Success Program, a restricted distribution system, aims to ensure the safe use of sodium oxybate.
    • This program includes centralized distribution, patient/physician registries, and educational components.
    • The comprehensive program enhances drug safety and patient compliance while mitigating diversion and abuse risks.