SODIUM OXYBATE
Details
- Status
- Prescription
- First Approved
- 2017-01-17
- Routes
- ORAL
- Dosage Forms
- SOLUTION
SODIUM OXYBATE Approval History
What SODIUM OXYBATE Treats
2 indicationsSODIUM OXYBATE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cataplexy
- Narcolepsy
SODIUM OXYBATE Boxed Warning
CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with sodium oxybate oral solution [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate oral solution during clinical trials in narcolepsy were receiving central nervous system stimulants ...
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with sodium oxybate oral solution [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate oral solution during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials (14) ] . Abuse and Misuse Sodium oxybate oral solution is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions (5.2) ] . Because of the risks of CNS depression and abuse and misuse, sodium oxybate oral solution is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Sodium Oxybate REMS Program [see Warnings and Precautions (5.3) ] . WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. See full prescribing information for complete boxed warning. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant, and respiratory depression can occur with sodium oxybate oral solution use (5.1 , 5.4) Abuse and Misuse Sodium oxybate oral solution is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death (5.2 , 9.2) Sodium oxybate oral solution is available only through a restricted program called the Sodium Oxybate REMS Program (5.3)
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SODIUM OXYBATE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy .
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with so...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.