Avadel Pharmaceuticals Announces Completion of Enrollment in Phase 3 REVITALYZ™ Trial in Idiopathic Hypersomnia
Avadel Pharmaceuticals plc - American Depositary Shares each representing one Ordinary Share (AVDL)
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Source: GlobeNewswire
- Data expected in Q2 2026 - DUBLIN, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 trial designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose in IH. The trial is evaluating study participants switching from immediate-release oxybates as well as those not currently taking oxybates. “Idiopathic hypersomnia 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
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