In the third quarter, low-sodium Xywav grew 30% year-over-year, despite additional competition, with continued adoption across both narcolepsy and idiopathic hypersomnia (IH), according to Jazz Pharmaceuticals’ latest financial results and business updates.
There were approximately 12,050 active Xywav patients exiting the third quarter, made up of approximately 9,500 narcolepsy patients and 2,550 idiopathic hypersomnia patients.
For idiopathic hypersomnia, Xywav remains the first and only US Food and Drug Administration (FDA)-approved treatment demonstrating improvement across multiple symptoms, including sleep inertia. According to Jazz, a survey of sleep specialists indicates that 70% anticipate increasing their prescribing of Xywav for idiopathic hypersomnia over the next six months, and new prescribers continued to grow in the third quarter.
During the quarter, Jazz continued to present data supporting its scientific leadership in sleep disorders and highlighting the impact of low-sodium Xywav for patients with narcolepsy and idiopathic hypersomnia. Highlights include:
- At Psych Congress 2023, a review of multiple clinical trials demonstrated oxybate improves sleep quality, sleep architecture, and measures of disrupted nighttime sleep in narcolepsy, independent of once- or twice-nightly dosing.
- At World Sleep 2023, results from the TENOR study of adults with narcolepsy showed the most common patient-reported reasons for utilizing Xywav individualized dosing regimens were to avoid morning grogginess, help fall asleep, and improve sleep quality. Results from another study, CV-RHYTHM, found patients with idiopathic hypersomnia experienced a greater burden of cardiovascular comorbidities, including stroke, heart attacks, and heart failure than those without idiopathic hypersomnia, emphasizing the importance of holistic management to treat under-recognized sleep disorders.
For Xyrem (sodium oxybate) oral solution, net product sales decreased 51% to $125.1 million in the quarter compared to the same period in 2022, reflecting the continued adoption of Xywav by patients with narcolepsy and the launch of high-sodium oxybate AGs in 2023.
Additionally, JZP441, a potent, highly selective oral orexin-2 receptor agonist designed to activate orexin signaling with the potential to be applicable in the treatment of narcolepsy, idiopathic hypersomnia, and other sleep disorders, continues to be investigated.
A phase 1 development program to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of JZP441 in sleep-deprived healthy volunteers is ongoing. The company expects initial proof of concept in healthy volunteers this year.