NDAORALSOLUTIONPriority Review
Approved
Jul 2002
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYREM (sodium oxybate) is an oral solution containing the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous GABA metabolite that acts as a CNS depressant. It is indicated for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients aged 7 years and older with narcolepsy. The exact mechanism of action remains unknown, but it is hypothesized to work through GABA-B receptor actions on noradrenergic, dopaminergic, and thalamocortical neurons. XYREM is the market-leading therapy for narcolepsy and has been the standard of care since FDA approval in 2002.
$0.1BPart D
7.4 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Started Jun 2023
155 enrolled
Narcolepsy
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
Started Sep 2019
24 enrolled
REM Sleep Behavior DisorderParkinson Disease
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
Started Oct 2014
106 enrolled
Narcolepsy With Cataplexy
Sodium Oxybate in Patients With Chronic Fatigue Syndrome.
Started Jun 2013
0Chronic Fatigue Syndrome
Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia
Started Mar 2010
129 enrolled
Fibromyalgia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.