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FT218
FT218 is a long-acting formulation of sodium oxybate that provides extended-release delivery to treat narcolepsy and other sleep-wake disorders.
FT218 is a long-acting formulation of sodium oxybate that provides extended-release delivery to treat narcolepsy and other sleep-wake disorders. Used for Narcolepsy type 1 with cataplexy, Narcolepsy type 2.
At a glance
| Generic name | FT218 |
|---|---|
| Also known as | LUMRYZ |
| Sponsor | Avadel |
| Drug class | Sodium oxybate (extended-release formulation) |
| Target | GABA-B receptor (indirect mechanism via sodium oxybate metabolite) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
FT218 uses Avadel's proprietary Micropump technology to deliver sodium oxybate in a sustained-release manner, allowing for once-nightly dosing instead of the multiple daily doses required by immediate-release sodium oxybate. Sodium oxybate is a central nervous system depressant that enhances slow-wave sleep and reduces cataplexy and excessive daytime sleepiness in narcolepsy patients.
Approved indications
- Narcolepsy type 1 with cataplexy
- Narcolepsy type 2
Common side effects
- Nausea
- Dizziness
- Headache
- Somnolence
- Enuresis
Key clinical trials
- Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) (PHASE3)
- An Open Label Study of FT218 in Subjects With Narcolepsy (PHASE3)
- Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy (PHASE3)
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:
- FT218 CI brief — competitive landscape report
- FT218 updates RSS · CI watch RSS
- Avadel portfolio CI