Abstract
The discovery of gamma-hydroxybutyrate (GHB) over 40 years ago led to its immediate use as a general anesthetic agent. Subsequent research demonstrated that GHB is an endogenous compound in the mammalian brain and current research suggests that GHB is a probable neurotransmitter. In the United States, reports of anabolic effects lead to its misuse among body builders during the 1980s while the intoxicating properties of the drug lead to its popularization as a substance of abuse during the 1990s. GHB became associated with reports of drug-facilitated sexual assault and cases of physical dependence and withdrawal. Efforts to ban GHB caused increased use of GHB analogues and pro-drugs. Against this backdrop, GHB was being developed for the treatment of narcolepsy, leading to the approval of Xyrem® (sodium oxybate) oral solution in 2002 for the treatment of cataplexy in patients with narcolepsy. A risk management program permits the safe handling and distribution of the approved product, minimizes the risk for diversion, provides professional and patient education about the risks and benefits of sodium oxybate, and includes physician and patient registries. Post-marketing surveillance indicates sodium oxybate has an acceptable safety profile and presents minimal risk for the development of physical dependence.
Keywords: GHB, sodium oxybate, gamma-hydroxybutyrate, risk management, drug safety
Current Drug Safety
Title: The Clinical Development of γ-Hydroxybutyrate (GHB)
Volume: 1 Issue: 1
Author(s): Gregory P. Wedin, Carl S. Hornfeldt and Lisa M. Ylitalo
Affiliation:
Keywords: GHB, sodium oxybate, gamma-hydroxybutyrate, risk management, drug safety
Abstract: The discovery of gamma-hydroxybutyrate (GHB) over 40 years ago led to its immediate use as a general anesthetic agent. Subsequent research demonstrated that GHB is an endogenous compound in the mammalian brain and current research suggests that GHB is a probable neurotransmitter. In the United States, reports of anabolic effects lead to its misuse among body builders during the 1980s while the intoxicating properties of the drug lead to its popularization as a substance of abuse during the 1990s. GHB became associated with reports of drug-facilitated sexual assault and cases of physical dependence and withdrawal. Efforts to ban GHB caused increased use of GHB analogues and pro-drugs. Against this backdrop, GHB was being developed for the treatment of narcolepsy, leading to the approval of Xyrem® (sodium oxybate) oral solution in 2002 for the treatment of cataplexy in patients with narcolepsy. A risk management program permits the safe handling and distribution of the approved product, minimizes the risk for diversion, provides professional and patient education about the risks and benefits of sodium oxybate, and includes physician and patient registries. Post-marketing surveillance indicates sodium oxybate has an acceptable safety profile and presents minimal risk for the development of physical dependence.
Export Options
About this article
Cite this article as:
Wedin P. Gregory, Hornfeldt S. Carl and Ylitalo M. Lisa, The Clinical Development of γ-Hydroxybutyrate (GHB), Current Drug Safety 2006; 1 (1) . https://dx.doi.org/10.2174/157488606775252647
DOI https://dx.doi.org/10.2174/157488606775252647 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
The Predictive Value of Lipid Markers in Vascular Disease
Current Pharmaceutical Design Selective VEGFR Inhibitors for Anticancer Therapeutics in Clinical Use and Clinical Trials
Current Pharmaceutical Design Hypertension, Cognitive Impairment and Dementia: An Epidemiological Perspective
Current Hypertension Reviews Pathophysiology, Diagnosis and Clinical Management of Hepatorenal Syndrome: From Classic to New Drugs
Current Vascular Pharmacology From Physiome to Pathome: A Systems Biology Model of Major Depressive Disorder and the Psycho-Immune-Neuroendocrine Network
Current Psychiatry Reviews Non-pharmacological Modulation of the Autonomic Nervous System for Heart Failure Treatment: Where do We Stand?
Current Vascular Pharmacology Interstitial Lung Disease in Sjogrens Syndrome
Current Rheumatology Reviews The Developing Role of Neuregulin1 In Cardiac Regenerative Stem Cell Therapy
Current Pharmaceutical Design Functional Genomics of Cardioprotection by Ischemic Conditioning and the Influence of Comorbid Conditions: Implications in Target Identification
Current Drug Targets Molecular Prevalence and Risk Factors of Gastroesophageal Reflux Disease in Hemodialysis Patients
Current Signal Transduction Therapy Silent Cerebral Damage in Hypertension
Current Hypertension Reviews Phosphoinositide-3 Kinase Signaling in Cardiac Hypertrophy and Heart Failure
Current Pharmaceutical Design Is High Oral Dose L-arginine Intake Effective in Leukoaraiosis? Preliminary Data, Study Protocol and Expert’s Opinion
Current Aging Science Fresh or Frozen Embryo Selection in Embryo Transfer: Live Birth Rates and Obstetric and Fetal/Neonatal Results
Current Women`s Health Reviews microRNA as Biomarkers and Regulator of Cardiovascular Development and Disease
Current Pharmaceutical Design MicroRNAs in Arterial Hypertension
Current Topics in Medicinal Chemistry Synthesis and Antithrombotic Activity Study of Some New Thienopyridine Derivatives
Letters in Organic Chemistry Perinatal Outcome in Women with Hypertensive Disorders of Pregnancy in Rural Tertiary Center of Northern India: A Retrospective Cohort Study”
Current Pediatric Reviews Editorial (Thematic Issue: New Technological and Clinical Trends in Blood Pressure Theranostics: Is it Time to Consider a Spatio-Temporal Approach?)
Current Pharmaceutical Design Matrix Gelatinases in Atherosclerosis and Diabetic Nephropathy: Progress and Challenges
Current Vascular Pharmacology