Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz - LARVOL DELTA

Sleep Actigraphy in Participants With Narcolepsy or Idiopathic Hypersomnia Taking Low-Sodium Oxybate: Results From the DUET Study (WSS 2025) - P4 | "Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) was a phase 4, prospective, multicentre, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating effectiveness of low-sodium oxybate (LXB; Xywav®) on daytime and nighttime-related signs and symptoms in participants with narcolepsy or idiopathic hypersomnia... Based on actigraphy, participants with narcolepsy taking LXB showed decreased awakenings and WASO duration, suggesting less disrupted sleep with treatment, compared with BL (off-treatment). Participants with idiopathic hypersomnia taking LXB showed decreased total nocturnal sleep time, and fewer awakenings, which may reflect more restorative sleep. These results augment previously reported polysomnography findings in these participants, adding to the established effectiveness of LXB treatment for narcolepsy and idiopathic hypersomnia."

Narcolepsy • Sleep Disorder

Sleep Architecture With Low-Sodium Oxybate Treatment in Narcolepsy: Results From the DUET Study (WSS 2025) - P4 | "Introduction: Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) was a phase 4, prospective, multicentre, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating effectiveness of low-sodium oxybate (LXB, Xywav®) on daytime and nighttime-related signs and symptoms, including polysomnography (PSG)-based sleep architecture and disrupted nighttime sleep (DNS), in participants with narcolepsy (type 1 [NT1] or 2 [NT2]) or idiopathic hypersomnia... Participants with narcolepsy taking open-label LXB experienced changes in duration and percentage of individual sleep stages, including increased N3 sleep and decreased N1 and REM, consistent with previous oxybate studies. Changes in N2 sleep and TST were negligible. Fewer shifts from deeper to lighter stages of sleep/wake were observed, suggesting improvement in DNS."

Narcolepsy • Sleep Disorder

Reduction in Sleep Inertia and Components of Daytime Sleepiness in Idiopathic Hypersomnia With Low-Sodium Oxybate Treatment in the Phase 4 DUET Study (WSS 2025) - P4 | "Low-sodium oxybate (LXB, Xywav®) is approved in the United States to treat idiopathic hypersomnia in adults and excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy... Compared with baseline, participants with idiopathic hypersomnia on optimised LXB treatment demonstrated reduced sleep inertia magnitude, less daytime sleepiness, and increased behavioural alertness."

P4 data • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Effect of Narcolepsy and Idiopathic Hypersomnia on Relationships: A Social Media Analysis (WSS 2025) - "Across all conversations that mentioned both sleeping and a partner, the most common topics identified were sleep medication usage, narcolepsy journey, Xyrem/Xywav, falling asleep, medical diagnosis journey, and vivid dreaming. These data suggest that nighttime sleep symptoms, including parasomnias, may be a source of concern within relationships of people with narcolepsy or IH. Sleepiness and bed sharing with a partner with narcolepsy or IH may cause relationship tension given the strong association with emotions with a negative connotation, such as anger and frustration."

Behavior Disorders • CNS Disorders • Mental Retardation • Narcolepsy • Psychiatry • Sleep Disorder

Sleep architecture with low-sodium oxybate treatment in idiopathic hypersomnia: results from the DUET study (WSS 2025) - P4 | "Introduction: Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) was a phase 4, prospective, multicentre, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating the effectiveness of low-sodium oxybate (LXB; Xywav®) treatment on daytime and nighttime-related signs and symptoms, including polysomnography (PSG)-based sleep architecture, in participants with idiopathic hypersomnia or narcolepsy... Participants with idiopathic hypersomnia treated with open-label LXB demonstrated reduced TST on ad libitum PSG versus BL, with corresponding increases in N3 sleep, decreases in N1, N2, and REM, and reduced stage shifts. These results suggest a potential correction of the underlying differences in sleep architecture between people with idiopathic hypersomnia and controls that have been described previously in a meta-analysis. These findings also represent the first evaluation of the impact of LXB treatment on PSG sleep..."

Narcolepsy • Sleep Disorder

Impact of Switching From High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in People With Narcolepsy (WSS 2025) - P4 | "Materials and XYLO, an open-label, single-arm study (NCT05869773), evaluated people with narcolepsy aged 18−70 years with screening systolic blood pressure (SBP) 130−155 mmHg taking twice-nightly high-sodium oxybate (SXB; Xyrem®) 6–9 g for ≥6 weeks, switching to low-sodium oxybate (LXB; Xywav®) at the same dosage/regimen for ≈6 weeks. Switching from SXB to LXB reduced daily treatment-related sodium intake in participants with narcolepsy and was associated with clinically meaningful BP reductions, consistent with evidence on dietary sodium effects."

Cardiovascular • Hypertension • Narcolepsy • Sleep Disorder

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Sleep Disorder

Extended-release Sodium Oxybate in Children (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2027 ➔ Jul 2027 | Initiation date: Feb 2025 ➔ Jul 2025 | Trial primary completion date: Jan 2027 ➔ Jun 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Narcolepsy • Sleep Disorder

A Patient-centric Clinical Trial Design to Comprehensively Evaluate Low-Sodium Oxybate in People with Idiopathic Hypersomnia or Narcolepsy. (PubMed, Neurol Ther) - P4 | "Low-sodium oxybate (LXB; Xywav®) is approved to treat idiopathic hypersomnia in adults and excessive daytime sleepiness or cataplexy in individuals aged ≥ 7 years with narcolepsy...Using a patient-centric design aiming to address participants' burden and improve their study experience, the DUET study will fill critical idiopathic hypersomnia and narcolepsy evidence gaps pertaining to sleep architecture (e.g., disrupted nighttime sleep) and response to LXB treatment, as well as provide data on outcomes that are meaningful to patients. Graphical abstract available for this article."

Journal • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

SUNCET: Low Sodium Oxybate as a Treatment for Nocturnal Cluster Headache (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Leiden University Medical Center

New P2 trial • Chronic Cluster Headache • Pain

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy (clinicaltrials.gov) - P4 | N=207 | Completed | Sponsor: Jazz Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Narcolepsy • Sleep Disorder

Drug-induced kidney stones: a real-world pharmacovigilance study using the FDA adverse event reporting system database. (PubMed, Front Pharmacol) - "The top 5 drugs most frequently linked to kidney stone cases were adalimumab (2,636 cases), infliximab (1,266 cases), interferon beta-1a (920 cases), sodium oxybate (877 cases), and teriparatide (836 cases). Notably, certain drugs like lansoprazole (ROR 7.2, 95% CI 6.62-7.84), Xywav (ROR 7.1, 95% CI 6.03-8.35), and teduglutide (ROR 5.54, 95% CI 4.83-6.36) showed significant risk signals...Our analysis of FAERS data revealed new risk signals for kidney stones not indicated in the labels of 33 drugs. Close monitoring is recommended when using these medications, and further research is needed to investigate the mechanisms behind drug-induced kidney stone formation."

Adverse events • Journal • Real-world evidence • Nephrology • Renal Calculi

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy (clinicaltrials.gov) - P4 | N=160 | Completed | Sponsor: Jazz Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Narcolepsy • Sleep Disorder

Efficacy and Safety of Low-Sodium Oxybate in Narcolepsy Patients With/Without Psychiatric/Neurologic Comorbidities (P12-2.004). (PubMed, Neurology) - P3 | "This post hoc analysis of a phase 3 trial (NCT03030599) assessed low-sodium oxybate (LXB; Xywav®) efficacy and safety in narcolepsy participants with or without psychiatric/neurologic comorbidities...Dr. Akerman has stock in Jazz Pharmaceuticals."

Clinical • Journal • Cataplexy • CNS Disorders • Depression • Excessive Daytime Sleepiness • Migraine • Mood Disorders • Narcolepsy • Pain • Psychiatry • Sleep Disorder

A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. (PubMed, J Clin Sleep Med) - P3 | "Establishing an MCID strengthens the SI-VAS value, adds context for findings related to sleep inertia in individuals with idiopathic hypersomnia from the phase 3 study, and aids clinicians in identifying clinically meaningful changes in sleep inertia to improve patient outcomes."

Clinical • Journal • Infectious Disease • Sleep Disorder

Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex (cannabidiol) at American Academy of Neurology Annual Meeting (PRNewswire) - "Jazz Pharmaceuticals plc...today announced that seven abstracts from across its neuroscience portfolio will be featured at the 77th Annual American Academy of Neurology Meeting (AAN) being held April 5-9, 2025, in San Diego...Highlights at the 2025 AAN Annual Meeting include:Two presentations showcasing updated results from the open-label, single-arm, Phase 4 DUET trial of adults with narcolepsy or IH, which evaluated the effectiveness and safety of Xywav on key sleep outcomes, daytime symptoms, and functional impacts, including cognitive complaints, work productivity, and daily activities. Novel analysis of real-world Epidiolex (cannabidiol) treatment patterns from U.S. specialty pharmacy data found the overall probability of persistence at one year was nearly 70% (69.9%) among new patients and underscores the importance of dose optimization."

P4 data • Real-world • Epilepsy • Narcolepsy • Sleep Disorder

Self-Reported Cognitive Complaints and Work Productivity in Participants With Narcolepsy or Idiopathic Hypersomnia After Low-Sodium Oxybate Treatment: Results From the Phase 4 DUET Study (AAN 2025) - P4 | "Objective:This study evaluated the effectiveness of low-sodium oxybate (LXB; Xywav®) on daytime symptoms and functional impacts, including cognitive complaints and work productivity, in participants with narcolepsy or idiopathic hypersomnia (IH)...Open-label LXB treatment was associated with improvements in cognitive complaints and work productivity in participants with narcolepsy or IH."

P4 data • Narcolepsy • Sleep Disorder

Efficacy and Safety of Low-Sodium Oxybate in Narcolepsy Patients With/Without Psychiatric/Neurologic Comorbidities (AAN 2025) - P3 | "Objective:This post hoc analysis of a phase 3 trial (NCT03030599) assessed low-sodium oxybate (LXB; Xywav®) efficacy and safety in narcolepsy participants with or without psychiatric/neurologic comorbidities...The efficacy and safety of LXB in narcolepsy participants with psychiatric/neurologic comorbidities were similar to those in participants without psychiatric/neurologic comorbidities."

Clinical • Cataplexy • CNS Disorders • Depression • Excessive Daytime Sleepiness • Migraine • Mood Disorders • Narcolepsy • Pain • Psychiatry • Sleep Disorder

Effectiveness and Safety of Low-Sodium Oxybate in Participants With Narcolepsy or Idiopathic Hypersomnia: Top-line Results From the Phase 4 DUET Study (AAN 2025) - P4 | "Objective:To evaluate effectiveness and safety of low-sodium oxybate (LXB; Xywav®) on excessive daytime sleepiness (EDS) in narcolepsy or idiopathic hypersomnia (IH), sleep architecture and sleep disruption based on polysomnography (narcolepsy cohort) and additional symptoms (IH cohort).Background:Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study (NCT05875974)...Participants with narcolepsy or IH taking open-label LXB showed improvements in ESS scores, reduced sleep stage shifts, increased deep sleep (N3), and reduced number of awakenings (narcolepsy) and improvements in ESS and IHSS scores (IH)."

Clinical • P4 data • CNS Disorders • Excessive Daytime Sleepiness • Infectious Disease • Influenza • Narcolepsy • Pain • Respiratory Diseases • Sleep Disorder

Extended-release Sodium Oxybate in Children (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Stanford University

New P2 trial • Narcolepsy • Sleep Disorder

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy (clinicaltrials.gov) - P4 | N=160 | Active, not recruiting | Sponsor: Jazz Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Mar 2025 | Trial primary completion date: Jun 2025 ➔ Feb 2025

Enrollment closed • Trial completion date • Trial primary completion date • Narcolepsy • Sleep Disorder

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy (clinicaltrials.gov) - P4 | N=207 | Active, not recruiting | Sponsor: Jazz Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Narcolepsy • Sleep Disorder

EFFICACY AND SAFETY OF LOW-SODIUM OXYBATE IN IDIOPATHIC HYPERSOMNIA WITH AND WITHOUT ASTHMA OR SLEEP APNEA: A SUBGROUP ANALYSIS OF A PHASE 3 STUDY (CHEST 2024) - P3 | "PURPOSE: Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration for the treatment of idiopathic hypersomnia in adults and for excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy... In participants with idiopathic hypersomnia, the efficacy and safety of LXB were similar in the presence or absence of asthma or sleep apnea. CLINICAL IMPLICATIONS: These findings support use of LXB in patients with idiopathic hypersomnia with asthma or mild or controlled sleep apnea and inform clinicians about the efficacy and safety of LXB in this patient population."

Clinical • P3 data • Asthma • Cataplexy • Cough • Excessive Daytime Sleepiness • Immunology • Narcolepsy • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy (clinicaltrials.gov) - P4 | N=170 | Recruiting | Sponsor: Jazz Pharmaceuticals | N=89 ➔ 170

Enrollment change • Narcolepsy • Sleep Disorder

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy (clinicaltrials.gov) - P4 | N=207 | Recruiting | Sponsor: Jazz Pharmaceuticals | Trial completion date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Nov 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Narcolepsy • Sleep Disorder