Research includes phase 4 study design of low-sodium oxybate, Xywav efficacy in narcolepsy with psychiatric and neurologic comorbidities, and assessments of idiopathic hypersomnia burden.

Summary: Jazz Pharmaceuticals announced that 13 abstracts, including five late-breaking abstracts, featuring new data from its sleep medicine portfolio will be presented at SLEEP 2024. Key presentations include studies on the phase 4 XYLO study design for low-sodium oxybate (Xywav), and the efficacy and safety of Xywav in narcolepsy patients with and without psychiatric and neurologic comorbidities. Additional presentations will address the clinical and economic burden of idiopathic hypersomnia, as well as data from the DUET study on the effects of Xywav on excessive daytime sleepiness and other outcomes.

Key Takeaways:

  1. Phase 4 XYLO Study on Xywav: Jazz Pharmaceuticals will present the design elements of the phase 4 XYLO study, which measures changes in 24-hour average systolic blood pressure after switching from high-sodium oxybate to low-sodium Xywav in patients with narcolepsy. 
  2. Efficacy and Safety of Xywav: An oral presentation will describe a post-hoc analysis demonstrating that the efficacy and safety of Xywav are consistent among narcolepsy patients with or without a history of psychiatric and neurologic comorbidities.
  3. Idiopathic Hypersomnia Burden: Two late-breaking poster presentations will utilize US National Health and Wellness Survey data to assess the clinical, humanistic, and economic burdens experienced by patients with idiopathic hypersomnia. 

Jazz Pharmaceuticals plc announced that 13 abstracts, including five late-breaking abstracts, featuring new data from across its sleep medicine portfolio will be presented at SLEEP 2024.

Two abstracts were selected for oral presentations, including one that showcases the design elements from the phase 4 XYLO study, which measures changes in 24-hour average systolic blood pressure after switching to low-sodium oxybate, Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution from a high-sodium oxybate oral solution in patients with narcolepsy. 

An additional oral presentation describes a post-hoc analysis of Xywav efficacy and safety data in patients with narcolepsy with or without a medical history of psychiatric and/or neurologic comorbidities, which found that the efficacy and safety of Xywav was similar among the two groups.

“For nearly two decades, we have been dedicated to advancing and delivering patient-centric solutions for those living with serious conditions, such as narcolepsy and idiopathic hypersomnia, which are chronic, debilitating neurologic sleep disorders that often require lifelong treatment,” says Kelvin Tan, MB BCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals, in a release. “I am proud of the range of data being presented at SLEEP 2024, which continues to demonstrate our commitment to the sleep community and the importance of addressing the needs of patients with these multi-symptom, and often underrecognized, sleep disorders.”

Highlights at SLEEP 2024

Additional highlights at SLEEP 2024 include:

  • Two late-breaking poster presentations, which utilized the US National Health and Wellness Survey data to assess the burden experienced by patients with idiopathic hypersomnia. One analysis examined the clinical and humanistic burden on US adults with idiopathic hypersomnia, which demonstrates the substantial comorbidity and health-related quality-of-life burden that patients experience. The second analysis examined the healthcare resource utilization and medical costs for US adults with idiopathic hypersomnia, which found patients reported significantly greater economic burden, including work productivity, compared to those without idiopathic hypersomnia.
  • Four posters, including two late-breaking abstracts, showcase design elements and baseline characteristics of participants (enrolled as of Feb 5) in the Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment (DUET) study. The DUET study is a phase 4, prospective study to assess the effect of Xywav treatment on excessive daytime sleepiness, polysomnography parameters, and functional outcomes in adults with idiopathic hypersomnia or narcolepsy.
  • A poster describing a post-hoc analysis of a phase 3 trial assessing the efficacy and safety of Xywav in participants with narcolepsy with and without cardiovascular or cardiometabolic comorbidities. The analysis demonstrates similar efficacy and safety of Xywav in participants with narcolepsy with and without these comorbidities.

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