Jazz Presents New Data on Xywav’s Impact on Narcolepsy and IH

Summary: At the 37th annual Psych Congress, Jazz Pharmaceuticals presented results from the phase 4 DUET trial on low-sodium Xywav, showing its effectiveness in treating excessive daytime sleepiness and improving sleep outcomes for adults with narcolepsy and idiopathic hypersomnia. Findings indicated notable improvements in polysomnography measures like nighttime awakenings and sleep stage stability, reinforcing Xywav’s benefits for managing these conditions.

Key Takeaways:

1. Positive Results for Xywav in Sleep Disorders: DUET trial data show Xywav improves daytime sleepiness and key polysomnography outcomes for narcolepsy and idiopathic hypersomnia patients.
2. Impact on Sleep Architecture: Xywav reduced nighttime awakenings and enhanced deep sleep in patients.
3. Broad Clinical Acceptance: Jazz presented multiple studies on Xywav’s safety and efficacy at the 37th Annual Psych Congress.

Jazz Pharmaceuticals announced that eight abstracts presenting data—including top-line results of the phase 4 DUET trial evaluating low-sodium oxybate on key sleep outcomes in adults with narcolepsy or idiopathic hypersomnia (IH)—from across its sleep portfolio were featured at the 37th annual Psych Congress. 

Notably, these DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) data show prospective improvements on excessive daytime sleepiness, as well as key polysomnography 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. 

The DUET trial is a phase 4, prospective, single-arm, open-label study to assess the effect of Xywav treatment on excessive daytime sleepiness, 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,” says Logan Schneider, MD, adjunct clinical associate professor of sleep medicine at Stanford Sleep Center and consultant neurologist at Stanford/VA Alzheimer’s Center, in a news release. “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 polysomnography-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<0.0001, while changes for total shifts from deeper to lighter stages of sleep, N3 sleep (deep sleep) duration in minutes, and number of awakenings were −13.1 (3.0), P<0.0001; 45.0 (8.8), P<0.0001; and −3.2 (0.9), P=0.0015, respectively (N=34 each).
• Xywav DUET IH Top-line Results (P165): First presentation of primary and key secondary outcomes in participants with IH show Xywav treatment resulted in improvements in excessive daytime sleepiness, measured by ESS and Idiopathic Hypersomnia Severity Scale (IHSS). Additionally, improvements were observed across Patient Global Impression of Change measures of overall symptoms, with new data on sleep inertia measured within the Patient Global Impression of Change. Statistically significant changes in ESS (N=40) and IHSS (N=36) from baseline to end of treatment were −8.4 (0.7), P<0.0001 and −15.5 (1.5), P<0.0001, respectively. Most participants reported improvement on the Patient Global Impression of Change overall (94.6%; N=37) and Patient Global Impression of Change sleep inertia inventory (81.1%; N=37).

“These DUET data are the first to show Xywav’s impact on polysomnography measures of nighttime awakenings, sleep stage shifts, and deep sleep for people living with narcolepsy, as well as improvements among adults with IH in key outcomes important for daily life,” says Kelvin Tan, MBBCh, MRCPCH, chief medical affairs officer of Jazz Pharmaceuticals, in a news release. “Jazz is committed to our leadership in sleep, as exemplified by our presentations at Psych Congress of the DUET trial data, which studied the effectiveness of low-sodium Xywav on symptoms of narcolepsy and IH by demonstrating improvements in measures which are key for patients to wake up more refreshed with improved wakefulness during the day.”

Jazz Presentations at Psych Congress

A full list of Jazz presentations follows below:

Photo caption: Xywav

File photo/Jazz Pharmaceuticals

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