Avadel Completes Enrollment in Phase 3 Trial of LUMRYZ for Idiopathic Hypersomnia
核心洞察
Avadel Pharmaceuticals has completed patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZ (sodium oxybate) extended-release oral suspension for idiopathic hypersomnia (搜索) treatment.
The double-blind, placebo-controlled trial will assess LUMRYZ's efficacy in reducing daytime sleepiness using the Epworth Sleepiness Scale as the primary endpoint at Week 14.
Results are expected in Q2 2026, potentially expanding LUMRYZ's approved indications beyond narcolepsy (搜索) to address an underserved patient population of approximately 40,000 diagnosed IH patients in the United States.
Avadel Pharmaceuticals plc announced the completion of patient enrollment in REVITALYZ, a Phase 3 clinical trial evaluating LUMRYZ (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (搜索) (IH). The milestone represents a significant step forward for patients with this rare and debilitating sleep disorder, with trial results expected in Q2 2026.
Trial Design and Objectives
REVITALYZ is designed as a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 trial evaluating the efficacy and safety of LUMRYZ administered as a once-at-bedtime dose in patients with idiopathic hypersomnia (搜索). The study includes participants switching from immediate-release oxybates as well as those not currently taking oxybate medications.
The primary objective focuses on demonstrating reduction in daytime sleepiness, measured by changes in total score on the Epworth Sleepiness Scale (ESS) at Week 14. Secondary endpoints will evaluate LUMRYZ's effect on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia (搜索) severity, and functional outcomes of sleep.
Addressing an Underserved Population
"Idiopathic hypersomnia (搜索) is a profoundly underserved, serious sleep disorder marked by extreme difficulty waking up, known as sleep inertia, and persistent, overwhelming daytime sleepiness," said Richard K. Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC, and Associate Clinical Professor at the University of South Carolina School of Medicine. "People living with IH need additional treatments. With a therapeutic dose designed to cover the nocturnal sleep period due to its extended-release formulation, LUMRYZ could become a valuable option, if approved, for these patients."
Idiopathic hypersomnia (搜索) is characterized by excessive daytime sleepiness (搜索) not attributable to other medical conditions. Symptoms typically include difficulty waking up (sleep inertia), prolonged sleep, and brain fog. According to claims data, approximately 40,000 patients are currently diagnosed with IH in the United States.
LUMRYZ's Established Track Record
LUMRYZ received FDA approval on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy (搜索) or excessive daytime sleepiness (搜索) in adults with narcolepsy (搜索). The approval was expanded on October 16, 2024, to include pediatric patients seven years of age and older with narcolepsy.
The FDA approval was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy (搜索). LUMRYZ demonstrated statistically significant and clinically meaningful improvements in three co-primary endpoints: excessive daytime sleepiness (搜索) (MWT), clinicians' overall assessment of patients' functioning (CGI-I), and cataplexy (搜索) attacks, for all three evaluated doses when compared to placebo.
Regulatory Recognition and Market Position
The FDA granted seven years of Orphan Drug Exclusivity to LUMRYZ for narcolepsy (搜索) treatment due to findings of clinical superiority relative to currently available oxybate treatments. The FDA determined that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
In June 2025, the FDA granted Orphan Drug Designation to LUMRYZ for IH treatment based on the plausible hypothesis that LUMRYZ may be clinically superior to existing treatments due to its once-nightly dosing for patients with IH, a chronic sleep disorder requiring potentially lifelong treatment.
Clinical Development Progress
"Completion of enrollment in the REVITALYZ trial marks an important step forward for this community," said Jennifer Gudeman, PharmD, Senior Vice President of Medical and Clinical Affairs at Avadel Pharmaceuticals. "The clinical benefits of LUMRYZ have already positively impacted the narcolepsy (搜索) community, and we are optimistic our extended-release sodium oxybate has potential to be a meaningful treatment for the IH community as well, if approved by the FDA."
LUMRYZ is currently approved only for treating cataplexy (搜索) or excessive daytime sleepiness (搜索) in patients seven years of age and older with narcolepsy (搜索). Avadel does not market, promote or offer patient support services for LUMRYZ use in any indication beyond narcolepsy.