Drugs / FT218
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06525077 | Aug 2024 → Mar 2026 | idiopathic hypersomnia | Avadel | Completed | Met primary |
| Phase 3 | NCT04451668 | Jun 2020 → Dec 2023 | hypersomnia, narcolepsy-cataplexy syndrome | Avadel | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-05-12 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From REVITALYZ℠ Phase 3 Study Evaluating LUMRYZ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the REVITALYZ℠ double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study evaluating the investigational use of LUMRYZ® (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-05-12 | Alkermes, Inc. | Alkermes Announces Positive Topline Results From REVITALYZ℠ Phase 3 Study Evaluating LUMRYZ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia alkermes.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FT218 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06525077 ↗ |
| Known as | ON-SXB | “Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR...” PMID 39263597 ↗ Aug 2024 |
| Known as | sodium oxybate | “Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR...” PMID 39263597 ↗ Aug 20241“FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension.” NCT06525077 ↗ |
| Route | Oral | “once nightly sodium oxybate extended release oral solution (FT218)” NCT04451668 ↗ |