LUMRYZ (sodium oxybate)

December 18, 2025 — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced completion of patient enrollment in REVITALYZ™, a multicenter, double-blind, placebo-controlled, randomized-withdrawal Phase 3 trial evaluating once-at-bedtime LUMRYZ™ (extended-release sodium oxybate oral suspension) as a potential treatment for idiopathic hypersomnia (IH). The study includes participants switching from immediate-release oxybates and those not currently taking oxybates. The primary endpoint is change from baseline in Epworth Sleepiness Scale (ESS) total score at Week 14; secondary endpoints include patient and clinician impression of change, IH severity, and functional outcomes of sleep. Avadel said data are expected in Q2 2026.

Business/clinical significance: Enrollment completion de-risks execution and moves LUMRYZ closer to a potential label expansion into IH, an underserved sleep disorder. LUMRYZ is already FDA-approved as the first once-at-bedtime oxybate for cataplexy or excessive daytime sleepiness in narcolepsy (adults since May 2023; pediatric patients ≥7 years since Oct. 2024) and received FDA Orphan Drug Designation for IH in June 2025.