Jazz Pharmaceuticals Presents Late-Breaking Phase 4 Data Showcasing Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution Treatment Outcomes in Narcolepsy at SLEEP 2025
First presentation of the Phase 4 XYLO switch study reports blood pressure reductions in patients with narcolepsy when switching from twice-nightly high- to low-sodium oxybate
Novel intermediate analysis from the DUET trial cohort of patients taking >9 grams evaluated safety and changes in daytime sleepiness in adults with narcolepsy taking Xywav dosages of 9-12 grams per night
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DUBLIN, June 9, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced late-breaking Phase 4 data evaluating treatment benefits of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution in people with narcolepsy. These results are two of Jazz's four late-breaking abstracts presented today as oral presentations at SLEEP 2025. The four late-breaking abstracts, selected for their scientific quality and innovation, comprise all industry-sponsored late-breaking oral presentations selected by the Associated Professional Sleep Societies (APSS). Xywav is the only low-sodium oxybate approved by the U.S. Food and Drug Administration for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia. The Xywav label recommends a nightly dose of 6-9 grams per night.
"People living with narcolepsy have an increased risk of developing cardiovascular and cardiometabolic comorbidities," said Richard J. Kovacs, MD, MACC, Chief Medical Officer, American College of Cardiology and Q.E. and Sally Russell Professor of Cardiology, Indiana University School of Medicine, and XYLO Steering Committee member. "Results from the XYLO study reinforce the importance of monitoring cardiovascular indicators, including blood pressure, and the need to minimize exposure to excess sodium in this at-risk population. Reducing cardiovascular risk and disease is an important goal for all healthcare providers."
"People with narcolepsy live with a complex, severe disorder and often must combat excessive daytime sleepiness and associated symptoms — but the challenges they face are not only limited to sleep," said Kelvin Tan, MB BCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals. "Results from the XYLO interim analysis add to the overwhelming body of evidence demonstrating the positive implications of limiting unnecessary sodium intake, and emphasize how choosing low-sodium oxybate, Xywav, rather than twice-nightly high-sodium oxybate helps reduce excessive sodium burden, a modifiable risk factor for cardiovascular disease, in people with narcolepsy."
Phase 4 XYLO Results Show Impact of Switching from Twice-Nightly High- to Low-Sodium Oxybate on Ambulatory Blood Pressure in People with NarcolepsyThe open-label, single arm Phase 4 XYLO switch trial (n=43) met its primary endpoint of change in mean 24-hour ambulatory systolic blood pressure (SBP) from baseline (taking twice-nightly high-sodium oxybate) to end-of-treatment (after six weeks on low-sodium oxybate, Xywav), with a −4.1 (−6.9, −1.4; P=0.0019) mmHg change. These results show that switching from twice-nightly high-sodium oxybate to the same dosage of low-sodium oxybate, Xywav, for approximately 6 weeks reduced daily treatment-related sodium intake and was associated with clinically meaningful blood pressure reductions in participants with narcolepsy, which was paralleled by 24-hour urinary sodium reduction. XYLO results are consistent with the extensive body of evidence on the benefits of reducing sodium intake.
The study also achieved key secondary endpoints, including mean change in ambulatory daytime SBP (-5.1 mmHg; P=0.0003) and mean change in seated resting (in-office) SBP (-9.2 mmHg; (P
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