Jazz Pharmaceuticals plc (Nasdaq: NASDAQ:JAZZ) today announced that thirteen abstracts, including five late-breaking abstracts, featuring new data from across its sleep medicine portfolio will be presented at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies being held
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," said Kelvin Tan, MB BCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals. "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."
Additional highlights at SLEEP 2024 include:
- Two late-breaking poster presentations, which utilized the U.S. 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
U.S. 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 forU.S. 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
February 5, 2024 ) 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.
The SLEEP 2024 abstracts are available online at the following link: https://academic.oup.com/sleep/issue/47/Supplement_1.
A full list of Jazz presentations follows:
Presentation Title | Lead Author | Presentation Number / Session / Date & Time (CT) |
Dual Presentations | ||
Design Elements for a Switch Study From High- to Low-Sodium Oxybate Evaluating Blood Pressure in Narcolepsy (XYLO) | V Somers | Oral Presentation Date/Time: Poster Number: 259 Poster Session: P-13 Poster Presentation Date/Time: |
Efficacy and Safety of Low-Sodium Oxybate in Narcolepsy Patients With/Without Psychiatric/Neurologic Comorbidities | C Chepke | Oral Presentation Date/Time: Poster Number: 263 Poster Session: P-13 Poster Presentation Date/Time: |
Poster Presentations | ||
Efficacy of Low-Sodium Oxybate in Narcolepsy Patients With and Without Cardiovascular or Cardiometabolic Disorders | BC Corser | Poster Number: 264 Poster Session: P-13 Poster Presentation Date/Time: |
Population Pharmacokinetic and Exposure-Response Analyses Supporting Individualized Dosing of Oxybate | C Chen | Poster Number: 256 Poster Session: P-13 Poster Presentation Date/Time: |
Supporting Patient Safety With Oxybate Therapy: A Survey of Patients and Prescribers | S Candler | Poster Number: 265 Poster Session: P-13 Poster Presentation Date/Time: |
Long-term Safety and Timing of Adverse Events With Low-Sodium Oxybate in a Phase 3 Idiopathic Hypersomnia Study | RK Bogan | Poster Number: 254 Poster Session: P-13 Poster Presentation Date/Time: |
A Qualitative Exploration of Patient and Healthcare Provider Perspectives on Oxybate Treatments for Narcolepsy | S Candler | Poster Number: 407 Poster Session: P-31 Poster Presentation Date/Time: |
Baseline Features of Participants With Narcolepsy: Insights From the DUET Study | A Cairns | Poster Number: 437 Poster Session: P-31 Poster Presentation Date/Time: |
Baseline Features of Participants With Idiopathic Hypersomnia: Insights From the DUET Study | D Plante | Poster Number: 432 Poster Session: P-31 Poster Presentation Date/Time: |
The Clinical and Humanistic Burden of Idiopathic Hypersomnia in | DT Plante | Poster Number: 434 Poster Session: P-31 Poster Presentation Date/Time: |
The Economic Burden of Idiopathic Hypersomnia in | C Drachenberg | Poster Number: 436 Poster Session: P-31 Poster Presentation Date/Time: |
Novel Design Elements to Evaluate Sleep Architecture and Outcomes in an Idiopathic Hypersomnia and Narcolepsy Study | DT Plante | Poster Number: 283 Poster Session: P-42 Poster Presentation Date/Time: |
Patient-Centric Design: Incorporating Patient Input Into a Clinical Study of Idiopathic Hypersomnia and Narcolepsy | DA Nichols | Poster Number: 304 Poster Session: P-42 Poster Presentation Date/Time: |