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LUMRYZ
Lumryz is a small molecule developed by Avadel, with its current ownership status remaining unchanged. Unfortunately, there is limited information available on its target, drug class, or approved indications. As a result, its commercial status, key safety considerations, and treatment specifics remain unclear. Further research is necessary to understand the full scope of Lumryz. Its development and approval status are also unknown.
At a glance
| Generic name | LUMRYZ |
|---|---|
| Sponsor | Avadel |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 (sod
Common side effects
- Enuresis
- Dizziness
- Nausea
- Vomiting
- Headache
- Somnolence
- Decreased Appetite
- Weight Decreased
- Anxiety
- Somnambulism
Serious adverse events
- CNS Depression
- Respiratory Depression and Sleep-Disordered Breathing
- Depression and Suicidality
- Parasomnias
- Abuse and Misuse
- Other Behavioral or Psychiatric Adverse Reactions
Key clinical trials
- Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) (PHASE3)
- Observational Study of LUMRYZ in Narcolepsy
- Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor (PHASE1)
- Extended-release Sodium Oxybate in Children (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LUMRYZ CI brief — competitive landscape report
- LUMRYZ updates RSS · CI watch RSS
- Avadel portfolio CI