First presentation of top-line efficacy and safety results from the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial of adults with narcolepsy or idiopathic hypersomnia
For U.S. media and investors only
DUBLIN, Oct. 31, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that eight abstracts presenting data from across its sleep portfolio were featured at the 37th annual Psych Congress, held in Boston from October 29 through November 2, 2024. The data includes the top-line results of the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, evaluating the effectiveness of low-sodium oxybate on key sleep outcomes in adults with narcolepsy or idiopathic hypersomnia (IH). Notably, these DUET data are the first to show prospective improvements on excessive daytime sleepiness (EDS), as well as key polysomnography (PSG) outcomes of sleep disruption, among adults with narcolepsy treated with Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution. Further, new DUET data evaluating nighttime Xywav treatment in adults with IH demonstrate clinical improvements on daytime symptoms, including sleep inertia measured by the Patient Global Impression of Change (PGIc).
The DUET trial is a Phase 4, prospective, single-arm, open-label study to assess the effect of Xywav treatment on EDS, polysomnography parameters, and functional outcomes in adults with narcolepsy or IH. Observed adverse events were consistent with the known safety profile of Xywav, with the most common including nausea, dizziness and headache.
"The new DUET data presented today demonstrate the impact of low-sodium Xywav treatment on key narcolepsy and idiopathic hypersomnia symptoms," said Logan Schneider, MD, adjunct clinical associate professor of sleep medicine, Stanford Sleep Center and Consultant Neurologist, Stanford/VA Alzheimer's Center. "These data build on our confidence that appropriate treatment can meaningfully impact the outcomes that matter to patients and their functioning."
Presentation highlights include:
- Xywav DUET Narcolepsy Top-line Results (P166): Novel analysis of primary and key secondary outcomes in participants with narcolepsy show improvements in daytime and nighttime symptoms with Xywav treatment compared to baseline across daytime sleepiness and PSG-based measures of sleep disruption, including sleep stage shifts from deeper to lighter stages of sleep, time spent in deep sleep, and number of awakenings. Specifically, the statistically significant change (least square mean, standard error) from baseline on the Epworth Sleepiness Scale (ESS) was −7.7 (0.9), P