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].

Core Insights - Jazz Pharmaceuticals presented new real-world evidence and Phase 4 data at World Sleep 2025 and the Psych Congress, highlighting the effectiveness of Xywav in treating narcolepsy and idiopathic hypersomnia [1][2][6] Group 1: Clinical Trial Results - The Phase 4 DUET trial demonstrated that low-sodium Xywav significantly improves daytime and nighttime symptoms in adults with narcolepsy or idiopathic hypersomnia [1][6] - Participants in the DUET trial experienced fewer awakenings and improved sleep measures, indicating enhanced sleep quality [6] - The analysis of the DUET data showed reduced sleep inertia and improved alertness among participants receiving optimized Xywav treatment [6] Group 2: Real-World Evidence - Real-world analyses indicated that individuals with narcolepsy or idiopathic hypersomnia face elevated risks of cardiovascular and cardiometabolic conditions, emphasizing the need for sodium intake reduction [6][8] - The data presented at the congresses reinforce the importance of understanding treatment impacts on both daytime and nighttime symptoms for patients [2][6] Group 3: Xywav Overview - Xywav is the only low-sodium oxybate approved by the FDA for treating cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy [11] - It is also the first FDA-approved treatment for idiopathic hypersomnia in adults, addressing multiple symptoms including excessive daytime sleepiness and sleep inertia [12] - Xywav has a significantly lower sodium content compared to other oxybate therapies, providing a safer option for patients sensitive to sodium intake [11][12] Group 4: Company Positioning - Jazz Pharmaceuticals aims to leverage both Phase 4 clinical trials and real-world evidence to enhance understanding of sleep disorders and improve treatment outcomes [2][40] - The company is dedicated to developing innovative therapies for serious diseases, with a focus on sleep disorders and oncology [40][41]