Jazz Pharmaceuticals plc announced financial and business results for the first quarter of 2023, highlighting continued adoption of its low-sodium oxybate Xywav for narcolepsy and idiopathic hypersomnia.
“Adoption of low-sodium Xywav continues to grow across both narcolepsy and idiopathic hypersomnia, and we expect Xywav to remain the oxybate of choice in 2023,” says Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, in a release.
Average active Jazz oxybate patients on therapy was approximately 17,400 in the quarter, an increase of 5% compared to the same period in 2022.
Jazz Pharmaceuticals provided the following updates:
Xywav for narcolepsy:
- There were approximately 9,050 narcolepsy patients taking Xywav exiting Q1.
- The benefits of reducing sodium intake resonate with patients and prescribers as the large majority of new-to-oxybate narcolepsy patients continue to be prescribed Xywav.
- The US Food and Drug Administration (FDA) continues to recognize seven years of Orphan Drug Exclusivity, through July 2027, for Xywav in narcolepsy. The FDA published its summary of clinical superiority findings stating that “Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem.” Further, the FDA stated that “the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated.”
- Xywav is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake.
Xywav for idiopathic hypersomnia:
- There were approximately 2,000 idiopathic hypersomnia patients taking Xywav exiting Q1.
- Recent Jazz survey of sleep specialists indicates 70% anticipate increasing their prescribing of Xywav for idiopathic hypersomnia over the next six months.
- Xywav is the first and only treatment approved by the FDA to treat the full condition of idiopathic hypersomnia.
- The FDA recognized Orphan Drug Exclusivity for idiopathic hypersomnia extending regulatory exclusivity to August 2028.
Xyrem oral solution:
- Xyrem net product sales decreased 28% to $178.1 million in 1Q23 compared to the same period in 2022, reflecting the continued adoption of Xywav by patients with narcolepsy and the launch of a high-sodium oxybate authorized generic in January 2023.
Jazz Pharmaceuticals also provided updates on JZP441, an investigational drug in its pipeline. JZP441, is 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.
A phase 1 development program to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of JZP441 in sleep-deprived healthy volunteers is ongoing, and the company expects initial proof of concept in healthy volunteers in 2023.