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Jazz Pharmaceuticals Presents Groundbreaking Findings on Xywav® Treatment

In an impressive display of innovation and commitment to sleep medicine, Jazz Pharmaceuticals plc showcased critical findings from Phase 4 clinical trials and real-world evidence regarding its flagship product, Xywav® (calcium, magnesium, potassium, and sodium oxybates), at two prominent events: World Sleep 2025 held in Singapore from September 5-10 and the 38th annual Psych Congress in San Diego from September 17-21. This revelation marks Jazz’s leadership in addressing sleep disorders such as narcolepsy and idiopathic hypersomnia (IH).

The Phase 4 DUET trial results, another highlight of Jazz’s groundbreaking presentations, spotlighted the distinctive treatment effects of low-sodium Xywav in adults grappling with narcolepsy and IH. This trial, designed as a prospective, single-arm, open-label study, meticulously assessed the impact of Xywav on excessive daytime sleepiness, polysomnography metrics, and overall functional outcomes.

Dr. Logan Schneider, an esteemed adjunct clinical associate professor at Stanford Sleep Center and consultant neurologist at the Stanford/VA Alzheimer’s Center, emphasized the importance of these findings. He stated, "These new DUET data continue to show the importance of measuring and understanding the impact of treatment in both daytime and nighttime symptoms, as well as other functional outcomes in people living with narcolepsy or idiopathic hypersomnia." These insights not only reinforce the significance of appropriate pharmacological interventions but also underscore the positive health implications for patients' holistic well-being.

Kelvin Tan, Chief Medical Affairs Officer at Jazz Pharmaceuticals, reflected on the company’s strategic approach, stating, "We are leveraging both the power of Phase 4 clinical trials and real-world evidence to provide clinically meaningful, high-quality research for the global sleep community, which informs the health complexities of people living with narcolepsy and idiopathic hypersomnia." This ongoing research not only expands the understanding of sleep disorders but also critically addresses the daily challenges faced by patients.

Presentation Highlights

The Jazz team presented a series of compelling findings that caught the attention of many at both congresses. Key highlights included:

• - Xywav DUET Sleep Actigraphy Results: A novel analysis of DUET data revealed improved sleep measures in participants with narcolepsy and IH who received Xywav treatment, showcasing fewer awakenings and decreased wake time after sleep onset.
• - Xywav DUET Sleep Inertia and Components of Daytime Sleepiness Results: This analysis showcased reduced sleep inertia and subjective evaluations of sleepiness upon waking, significantly benefiting participants in their daily functionality.
• - Real-World Risk of Sodium-Associated Negative Clinical Outcomes: Jazz’s real-world data assessment identified elevated risks of cardiovascular, cardiometabolic, and renal negative clinical outcomes among individuals with narcolepsy or IH, accentuating the necessity of sodium reduction for these patients.
• - Xywav DUET >9 Gram Cohort: An analysis of participants taking 9-12 grams of Xywav nightly showed added symptom relief, including notable reductions in the Epworth Sleepiness Scale and Narcolepsy Severity Scale scores.

Conclusion

Within the backdrop of major international sleep and psychiatry congresses, Jazz Pharmaceuticals delivered remarkable insights that could reshape treatment paradigms for narcolepsy and IH. These new findings underline the profound impact of effective pharmacological interventions and the commitment of Jazz to advancing research in sleep medicine. As the global health community continues to grapple with the nuances of sleep disorders, the emerging evidence presented by Jazz could pave the way for enhanced treatment options and improved patient care pathways in the future.

For more detailed abstracts presented at World Sleep 2025, visit ws2025.abstractserver.com/program. Further insights from the Psych Congress can be accessed via the conference mobile application, with abstracts being made available through the Psychiatry Behavioral Health Learning Network 30-60 days post-congress.