1. AVDL completed patient enrollment in REVITALYZ trial for LUMRYZ. 2. LUMRYZ aims to treat idiopathic hypersomnia (IH) effectively. 3. Approximately 40,000 IH patients exist in the U.S. 4. LUMRYZ shows potential based on previous narcolepsy approvals. 5. Results from REVITALYZ are expected to impact future revenues.
FAQ
Why Bullish?
The completion of enrollment in the REVITALYZ trial for LUMRYZ is a positive indicator for AVDL. Positive results could lead to FDA approval, expanding AVDL's market and revenue base.
How important is it?
The enrollment completion is a critical milestone that suggests potential future revenue growth through a new treatment, raising investor interest.
Why Long Term?
If LUMRYZ is approved for IH, it could significantly enhance AVDL’s revenue streams over several years, similar to the gradual revenue growth experienced after their initial narcolepsy approval.
Related Companies
Avadel Pharmaceuticals Completes Enrollment in Phase 3 REVITALYZ™ Trial for Idiopathic Hypersomnia
Dublin, December 18, 2025 (GLOBE NEWSWIRE) - Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company dedicated to improving lives through innovative medicines, has announced that patient enrollment in its Phase 3 trial, REVITALYZ, has been successfully completed. This trial is evaluating LUMRYZ™ (sodium oxybate) extended-release oral suspension as a promising treatment for idiopathic hypersomnia (IH), a severe sleep disorder characterized by excessive daytime sleepiness.
About the REVITALYZ Trial
The REVITALYZ trial is designed as a double-blind, placebo-controlled, randomized withdrawal study involving multiple centers. Its primary aim is to assess the efficacy and safety of LUMRYZ when administered as a once-at-bedtime dose. The study will include participants transitioning from immediate-release oxybate formulations, as well as those not currently using oxybates.
Dr. Richard K. Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants and Associate Clinical Professor at the University of South Carolina, emphasized, “Idiopathic hypersomnia is a profoundly underserved, serious sleep disorder. Patients experience extreme difficulty waking up and persistent daytime sleepiness. LUMRYZ's extended-release formulation may provide a valuable treatment option, pending FDA approval.”
Trial Objectives and Endpoints
The primary objective of the REVITALYZ trial is to demonstrate a reduction in daytime sleepiness through the Epworth Sleepiness Scale (ESS) at Week 14. Additionally, secondary endpoints will measure the following:
- Patient and clinician impression of change
- Severity of idiopathic hypersomnia
- Functional outcomes related to sleep
Jennifer Gudeman, PharmD, Senior Vice President of Medical and Clinical Affairs at Avadel Pharmaceuticals, commented, “The completion of enrollment marks a crucial step forward for the IH community. We are optimistic about the potential impact of LUMRYZ on this patient population, following its positive reception in the narcolepsy community.”
Understanding Idiopathic Hypersomnia
Idiopathic hypersomnia is a rare and debilitating disorder that causes significant daytime sleepiness unrelated to other medical conditions. Patients commonly experience symptoms such as:
- Difficulty waking up (sleep inertia)
- Prolonged sleep duration
- Brain fog and cognitive impairments
Currently, around 40,000 individuals in the United States are diagnosed with IH, highlighting the need for more effective treatments.
LUMRYZ™: A New Treatment for Narcolepsy
LUMRYZ, an extended-release sodium oxybate formulation, received FDA approval on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy and excessive daytime sleepiness in adults with narcolepsy. On October 16, 2024, the FDA expanded this approval for use in pediatric patients aged seven years and older.
The FDA’s decision was backed by data from the pivotal Phase 3 REST-ON™ trial, which revealed significant improvements across multiple endpoints in adult patients with narcolepsy. LUMRYZ has been granted seven years of Orphan Drug Exclusivity due to its demonstrated clinical superiority over existing treatments.
Important Safety Information
Patients taking LUMRYZ™ should be aware of the risks associated with the medication, particularly when combined with other central nervous system (CNS) depressants. Potential serious side effects include:
- Respiratory depression
- Low blood pressure
- Changes in alertness, including drowsiness
- Severe mental health issues
Because of these risks, LUMRYZ is available only by prescription and must be filled through certified pharmacies within the LUMRYZ REMS program. For further details on the trial, please visit clinicaltrials.gov (Identifier: NCT06525077).