LUMRYZ · program
LUMRYZ (sodium oxybate extended-release) for Idiopathic Hypersomnia
LUMRYZ (once-nightly sodium oxybate ER) is in Phase 3 development for idiopathic hypersomnia. The pivotal REVITALYZ study (NCT06525077), a double-blind, placebo-controlled, randomized-withdrawal, multicenter trial, reported positive topline results on 2026-05-12, meeting its primary endpoint (change in Epworth Sleepiness Scale, p<0.0001) and all key secondary endpoints (PGI-C, IHSS, and ESS worsening on placebo, each p<0.0001). Alkermes plans to file a supplemental New Drug Application (sNDA) with the FDA by the end of 2026. LUMRYZ is already FDA-approved for cataplexy or excessive daytime sleepiness in patients 7+ with narcolepsy, which is the lead indication; idiopathic hypersomnia is a label-expansion program.
Development timeline
- metREVITALYZ Phase 3 positive topline: LUMRYZ met the primary ESS endpoint and all key secondary endpoints (PGI-C, IHSS, ESS worsening on placebo), each p<0.0001, in adults with idiopathic hypersomnia; sNDA planned by end of 2026.↗
- REVITALYZ Phase 3 study reached primary completion / completion (registry actual date).
- REVITALYZ Phase 3 study (NCT06525077) in idiopathic hypersomnia initiated (registry start date); sponsored by Avadel Pharmaceuticals.
Readouts
- 2026-05-12ReportedTopline datametNCT06525077
REVITALYZ Phase 3 positive topline: LUMRYZ met the primary ESS endpoint and all key secondary endpoints (PGI-C, IHSS, ESS worsening on placebo), each p<0.0001, in adults with idiopathic hypersomnia; sNDA planned by end of 2026. ↗
Clinical trials in Idiopathic Hypersomnia
NCT06525077REVITALYZPhase 3Completedn=157
A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH) (REVITALYZ)
metsecondaryIdiopathic Hypersomnia Severity Scale (IHSS) total score (<0.0001)
Key secondary endpoint met: participants randomized to placebo had statistically significant worsening in IHSS total score vs those continuing LUMRYZ (p<0.0001).
metprimaryChange in total Epworth Sleepiness Scale (ESS) score (end of stable-dose period to end of double-blind randomized-withdrawal period) (<0.0001)
LUMRYZ met the primary endpoint: statistically significant improvement in excessive daytime sleepiness vs placebo measured by change in total ESS score during the randomized-withdrawal period (p<0.0001). Participants randomized to placebo showed significant worsening in ESS vs those continuing LUMRYZ.
metsecondaryPatient Global Impression of Change (PGI-C) (<0.0001)
Key secondary endpoint met: participants randomized to placebo had statistically significant worsening on PGI-C vs those continuing LUMRYZ (p<0.0001).
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| LUMRYZ (sodium oxybate extended-release oral suspension)extended-release (once-at-bedtime) oral suspension; sodium oxybate granules reconstituted in water 4.5 g, 6 g, 7.5 g, or 9 g sodium oxybate per single bedtime dose (packets) | Oral | Once nightly | Tmax 1.5 h |
Mechanism of action
Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous metabolite of GABA. Its CNS-depressant and sleep-promoting effects are mediated principally by agonist activity at GABA-B receptors (low, millimolar potency), with additional activity at the distinct high-affinity GHB receptor. Agonism of GABA-B receptors enhances inhibitory neurotransmission, consolidating slow-wave sleep and reducing next-day sleepiness.
| Target | Action | Affinity |
|---|---|---|
| GABA-B receptorprimaryGABBR1 | Agonist | —ⓘ |
| GHB receptorGHBR | Agonist | —ⓘ |
← Full LUMRYZ compound page (identity, identifiers, all indications)
Sources
- Alkermes Announces Positive Topline Results From REVITALYZ Phase 3 Study Evaluating LUMRYZ (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia — Alkermes plc
- GABAB1 subunit (GABBR1) - GABA-B receptors — IUPHAR/BPS Guide to Pharmacology
- LUMRYZ (sodium oxybate) for extended-release oral suspension — FDA label (DailyMed) — DailyMed / FDA
- Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) - NCT06525077 — ClinicalTrials.gov
- Sodium Oxybate - StatPearls (mechanism: GHB / GABA-B) — StatPearls, NCBI Bookshelf