Supplemental New Drug Application Submitted for Mixed-Salt Oxybates for Idiopathic Hypersomnia Treatment
A supplemental new drug application (sNDA) has been submitted to the Food and Drug Administration (FDA) for marketing approval of the mixed calcium, magnesium, potassium, and sodium oxybates (Xywav; Jazz Pharmaceuticals, Philadelphia, PA) oral solution for treatment for adults with idiopathic hypersomnia. If approved, Xywav will be the first and only approved treatment for adults with idiopathic hypersomnia.
"This sNDA submission brings us one step closer to making this important treatment option available to patients living with idiopathic hypersomnia. As a long-standing leader in sleep medicine, Jazz continues to invest in developing innovative treatments for patients with significant unmet needs. Jazz has spent over a decade researching the lower-sodium oxybate product, Xywav, in both narcolepsy and idiopathic hypersomnia," said Robert Iannone, MD, MSCE, executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "Our purpose is to innovate to transform the lives of patients and we are committed to collaborating with regulators, sleep experts and patients to deepen our understanding of sleep disorders, and the science around sleep medicine."
The application is supported by results from a phase 3 clinical trial (NCT03533114) with a withdrawal design. After titration and optimization, all participants took the mixed-salt oxybates for a stable-dose period of 2 weeks and then were randomly assigned 1:1 randomization to receive mixed-salts oxybates or placebo for 2 weeks. Improvement was measured with the Epworth Sleepiness Scale (ESS) score, the Patient Global Impression of Change (PGI-c), and the Idiopathic Hypersomnia Severity Scale (IHSS) score. The IHSS is a recently developed, validated scale, and is a self-report measure of the severity, frequency, and consequences of the key symptoms of idiopathic hypersomnia. Detailed results have been accepted for presentation at an upcoming scientific meeting.
"People with idiopathic hypersomnia often live without an accurate diagnosis for a long time — and some are never diagnosed at all. Meanwhile, they struggle to keep up with school, work and relationships," said Diane Powell, board chair and chief officer executive, Hypersomnia Foundation. "We are encouraged by Jazz's progress and the possibilities for people living with idiopathic hypersomnia."