Announcement • 18h
Jazz Pharmaceuticals Presents Comprehensive Data SLEEP 2026 Highlighting Broad Treatment Effects of Xywav® Oral Solution for People with Narcolepsy and Idiopathic Hypersomnia
Jazz Pharmaceuticals plc announced that the company will present 21 abstracts, including 11 late-breaking abstracts, at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), taking place June 14-17, 2026, in Baltimore. The robust breadth of data reflects Jazz's continued focus on advancing treatment for rare and difficult-to-treat sleep disorders with new clinical research and real-world evidence evaluating Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in patients with narcolepsy and idiopathic hypersomnia. Key highlights at SLEEP 2026 include: An oral presentation featuring a post-hoc analysis of the DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) study, examining objective and subjective sleep inertia in participants with narcolepsy (type 1 and type 2) taking Xywav. Two poster presentations reporting post-hoc analyses of the DUET study exploring outcomes for idiopathic hypersomnia participants taking Xywav treatment, with one evaluating objective and patient-reported sleep inertia and the other exploring outcomes of Xywav treatment when stratified by individual ideal sleep duration. A poster presentation showcasing changes in hypersomnolence among participants with narcolepsy taking Xywav dosages >9 grams per night, compared to 9 grams at baseline, in the DUET study. The current recommended dosage of Xywav for adults with narcolepsy is 6-9 grams per night. Six poster presentations featuring comprehensive findings from the real-world, longitudinal, mixed-methods LYRICAL study, examining the treatment experience and dosing patterns of U.S. adults with idiopathic hypersomnia or narcolepsy taking Xywav. Two poster presentations detailing the development of conceptual disease models of the symptoms and impact of narcolepsy type 1 and narcolepsy type 2, respectively, from the patient perspective to better understand the most bothersome symptoms and meaningful impacts. Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem (sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose whereas other high sodium oxybates have 1,640 mg at the equivalent dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night. Xywav is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake. Xywav is also the first and only FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults. The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons. The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence. Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS. XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving CNS stimulants. The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a REMS called the XYWAV and XYREM REMS. XYWAV is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (e.g., post- or perioperative) is required, interruption of treatment with XYWAV should be considered. After first initiating treatment and until certain that XYWAV does not affect them adversely (e.g., impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and periodically thereafter. XYWAV is a Schedule Ill controlled substance.