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

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

EFFICACY AND SAFETY OF LOW-SODIUM OXYBATE IN NARCOLEPSY PATIENTS WITH/WITHOUT PSYCHIATRIC/NEUROLOGIC COMORBIDITIES (SLEEP 2024) - P3 | "Low-sodium oxybate (LXB; Xywav®) is an FDA-approved treatment for cataplexy or excessive daytime sleepiness in patients ≥7 years old with narcolepsy and for adults with idio pathic hypersomnia... In this post hoc analysis of a phase 3 trial in patients with narcolepsy, the efficacy and safety of LXB in participants with psychiatric and/or neurologic comorbidities were similar to those in participants without such comorbidities."

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

LONG-TERM SAFETY AND TIMING OF ADVERSE EVENTS WITH LOW-SODIUM OXYBATE IN A PHASE 3 IDIOPATHIC HYPERSOMNIA STUDY (SLEEP 2024) - P3 | "Introduction: Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration for the treatment of idiopathic hypersomnia in adults... In this study of LXB in participants with idiopathic hypersomnia, the common TEAEs (≥5% of participants) were consistent with the known safety profile of oxybate, peaked early (generally within 5 weeks), and were mild to moderate in sever ity, in both treatment-naive participants and participants taking alerting agents."

Adverse events • Clinical • P3 data • CNS Disorders • Mood Disorders • Pain • Psychiatry • Sleep Disorder

EFFICACY OF LOW-SODIUM OXYBATE IN NARCOLEPSY PATIENTS WITH AND WITHOUT CARDIOVASCULAR OR CARDIOMETABOLIC DISORDERS (SLEEP 2024) - P3 | "Introduction: Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy, and idiopathic hypersomnia in adults. LXB con tains the same active moiety as high-sodium oxybates (sodium oxybate [SXB, Xyrem®] and fixed-dose SXB [Lumryz™]) but with 92% less sodium... In this post-hoc analysis, the efficacy and safety of LXB were similar in participants with narcolepsy with and with out CV/CM comorbidities."

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

Accidental calcium, magnesium, potassium and sodium oxybates (Xywave) overdose: mistiming of a single night's narcolepsy medication leading to respiratory failure requiring mechanical ventilation. (PubMed, BMJ Case Rep) - "This case should serve as a warning to emergency physicians to be on the lookout for GHB as part of the differential diagnosis for patients with narcolepsy presenting with altered mental status. It should also serve as a warning to patients and prescribers that this medication can have outcomes that require immediate medical intervention."

Journal • CNS Disorders • Critical care • Depression • Narcolepsy • Psychiatry • Respiratory Diseases • Sleep Disorder

Clear-Brain: Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Leiden University Medical Center

New P2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Case of Psychosis Associated with Mixed Oxybate Salts (Xywav) in Idiopathic Hypersomnia (APA 2024) - "Her home medications include duloxetine for depression, anxiety, and fibromyalgia; methylphenidate, mixed amphetamines, and clarithromycin for IH...Here, a patient without history of psychosis or bipolar disorder presented with acute psychosis three weeks following an increase in Xywav that resolved after discontinuation of Xywav and initiation of low dose risperidone. Clinicians should carefully monitor patients who are started on Xywav for IH for neuropsychiatric side effects."

Clinical • Bipolar Disorder • CNS Disorders • Depression • Fibromyalgia • Mood Disorders • Musculoskeletal Pain • Narcolepsy • Pain • Psychiatry • Rheumatology • Sleep Disorder

Effectiveness and optimization of low-sodium oxybate in participants with narcolepsy switching from a high-sodium oxybate: data from the SEGUE study. (PubMed, J Clin Sleep Med) - P4 | "Most participants switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy. Effectiveness of oxybate treatment was maintained on LXB, and most participants preferred LXB to SXB. No new safety or tolerability issues were identified."

Journal • Cardiovascular • Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Effectiveness and Optimization of Low-sodium Oxybate in Participants with Narcolepsy Switching from Sodium Oxybate: Final Data from the Substitution of Equal Grams of Uninterrupted Xyrem to Xywav (SEGUE) Study (AAN 2024) - "Most participants with narcolepsy switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy. Effectiveness of oxybate treatment (ESS) was maintained after transition, and most preferred LXB over SXB."

Cataplexy • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Effects of Oxybate on Sleep, Sleep Architecture, and Disrupted Nighttime Sleep (AAN 2024) - "Sodium oxybate (SXB; Xyrem®), dosed twice nightly, is approved to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. Once-nightly sodium oxybate (ON-SXB; Lumryz™) and low-sodium oxybate (Xywav®) have been approved for the same indication...A clinical data review shows that oxybate, independent of once- or twice-nightly dosing, is effective in improving sleep, measures of sleep architecture, and DNS in participants with narcolepsy."

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

Efficacy of Low-sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Participants with Idiopathic Hypersomnia (AAN 2024) - P3 | "Objective:Analyze response to low-sodium oxybate (LXB; Xywav®) by baseline sleep inertia in a phase 3 trial (NCT03533114) in participants with idiopathic hypersomnia.Background:Sleep inertia (difficulty awakening) is a common, debilitating symptom of idiopathic hypersomnia.Design/Participants received open-label LXB for 10–14 weeks, followed by a 2-week stable-dose period (SDP)...LXB improved sleep inertia, and improved sleepiness and overall idiopathic hypersomnia symptoms regardless of baseline sleep inertia."

Clinical • P3 data • Sleep Disorder