LUMRYZ
Details
- Status
- Prescription
- First Approved
- 2023-05-01
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
LUMRYZ Approval History
What LUMRYZ Treats
3 indicationsLUMRYZ is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cataplexy
- Excessive Daytime Sleepiness
- Narcolepsy
LUMRYZ Boxed Warning
CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE Central Nervous System Depression LUMRYZ (sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials (14) ] . Abuse and Misuse LUMRYZ (sodium oxyba...
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE Central Nervous System Depression LUMRYZ (sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials (14) ] . Abuse and Misuse LUMRYZ (sodium oxybate) 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, LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS [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 • LUMRYZ is a CNS depressant, and respiratory depression can occur with LUMRYZ use ( 5.1 , 5.4 ) Abuse and Misuse • LUMRYZ 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 ) LUMRYZ is available only through a restricted program called the LUMRYZ REMS ( 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.
LUMRYZ FDA Label Details
ProIndications & Usage
FDA Label (PDF)LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy .
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE Central Nervous System Depression LUMRYZ (sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses [see Warnings and Precauti...
LUMRYZ Patents & Exclusivity
Patents (484 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.