Jazz Pharmaceuticals Shares 2024 Psych Congress Data on Xywav® Benefits for Narcolepsy and Hypersomnia

Jazz Pharmaceuticals plc unveiled eight abstracts showcasing data from their sleep portfolio at the 37th annual Psych Congress held in Boston. Among the notable findings were the top-line results from the Phase 4 DUET trial, which assessed the efficacy of low-sodium oxybate on key sleep outcomes for adults with narcolepsy or idiopathic hypersomnia (IH). This trial is the first to show improvements in excessive daytime sleepiness (EDS) and polysomnography (PSG) outcomes for narcolepsy patients treated with Xywav®, an oral solution containing calcium, magnesium, potassium, and sodium oxybates. Additionally, the trial revealed clinical improvements in daytime symptoms for adults with IH.

The DUET trial is a Phase 4, prospective, single-arm, open-label study designed to evaluate the effects of Xywav on EDS, PSG parameters, and functional outcomes in adults with narcolepsy or IH. Common adverse events observed were nausea, dizziness, and headache, consistent with Xywav's known safety profile.

Logan Schneider, MD, a clinical associate professor at Stanford Sleep Center, emphasized the significance of these findings, noting that they highlight the impact of low-sodium Xywav treatment on critical symptoms of narcolepsy and IH.

Key presentations included:
- Xywav DUET Narcolepsy Top-line Results: Participants with narcolepsy showed improvements in daytime and nighttime symptoms with Xywav treatment compared to baseline. The statistically significant changes from baseline in the Epworth Sleepiness Scale (ESS) and other PSG-based measures of sleep disruption were highlighted.
- Xywav DUET IH Top-line Results: Participants with IH demonstrated improvements in EDS, measured by ESS and Idiopathic Hypersomnia Severity Scale (IHSS), and overall symptoms as assessed by the Patient Global Impression of Change (PGIc).

Kelvin Tan, MBBCh, MRCPCH, Chief Medical Affairs Officer at Jazz Pharmaceuticals, remarked that these DUET data are pivotal in showing Xywav's impact on nighttime awakenings, sleep stage shifts, and deep sleep for those with narcolepsy, as well as improvements in key outcomes for adults with IH.

Narcolepsy is a chronic neurological sleep disorder characterized by excessive daytime sleepiness (EDS) and an inability to regulate sleep-wake cycles. This often results in sudden sleep attacks that can occur at inappropriate times, significantly impacting a person's psychological, social, and professional life. Narcolepsy patients face increased risks for hypertension, cardiometabolic morbidity, and other serious health conditions. Early access to effective, low-sodium treatments like Xywav can greatly improve their quality of life.

Idiopathic hypersomnia, another debilitating neurological sleep disorder, encompasses symptoms beyond chronic EDS, such as prolonged but non-restorative sleep, cognitive impairment, and severe sleep inertia. Although similar to narcolepsy, it has distinct diagnostic criteria. The disorder can significantly affect social, educational, and occupational functioning. Despite the challenges in identifying and diagnosing IH, effective pharmacological treatments are crucial for patients.

Xywav stands out as the only low-sodium oxybate approved by the U.S. FDA for treating cataplexy or EDS in patients as young as seven with narcolepsy. It is noted for its reduced sodium content compared to other high-sodium oxybates, offering a safer option for long-term use. The exact mechanism behind Xywav's therapeutic effects is not fully understood, but it is believed to involve actions on GABAB receptors during sleep.

Overall, the data presented at the Psych Congress underscore Jazz Pharmaceuticals' commitment to advancing sleep disorder treatments, with Xywav showing promising results for improving the lives of those affected by narcolepsy and idiopathic hypersomnia.