Avadel Pharmaceuticals Announces Completion of Enrollment in Phase 3 REVITALYZ™ Trial in Idiopathic Hypersomnia

Core Viewpoint - Avadel Pharmaceuticals has completed patient enrollment in the REVITALYZ Phase 3 trial for LUMRYZ, an extended-release oral suspension of sodium oxybate, aimed at treating idiopathic hypersomnia (IH) [2][5]. Group 1: Trial Details - REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal trial assessing the efficacy and safety of LUMRYZ administered as a once-at-bedtime dose for IH patients [3]. - The primary objective is to demonstrate a reduction in daytime sleepiness, measured by the change in total score on the Epworth Sleepiness Scale (ESS) at Week 14 [4]. - Secondary endpoints will evaluate additional efficacy parameters, including patient and clinician impressions, severity of IH, and functional outcomes of sleep [4]. Group 2: Market Need and Potential - Idiopathic hypersomnia is a serious sleep disorder affecting approximately 40,000 diagnosed patients in the U.S., characterized by extreme difficulty waking up and persistent daytime sleepiness [6]. - The approval of LUMRYZ could provide a valuable treatment option for IH patients, as current treatments are limited [4][5]. Group 3: Background on LUMRYZ - LUMRYZ was approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy [7]. - The drug received Orphan Drug Designation for IH in June 2025, indicating its potential clinical superiority over existing treatments [9][10]. - LUMRYZ's once-nightly dosing regimen is designed to improve patient care by avoiding nocturnal arousal for a second dose [9].