Jazz Pharmeuticals announces Phase III data of idiopathic hypersomnia treatment
pharmafile | January 6, 2022 | News story | Business Services |
Jazz Pharmaceuticals have announced that positive data, from the Phase III of Xywav oral solution for the treatment of adults with idiopathic hypersomnia, are published online in The Lancet Neurology.
The Phase III trial was a multicenter, placebo-controlled, double-blind, randomised withdrawal study into Xywav (calcium, magnesium, potassium, and sodium oxybates). The results showed clinically meaningful and statistically significant differences with Xywav compared to placebo, in the Epworth Sleepiness Scale (ESS) score and key secondary endpoints. These included measures that assessed patients’ perceptions of the changes in their idiopathic hypersomnia overall (PGIc), symptom severity, including excessive daytime sleepiness (EDS), sleep inertia and prolonged sleep duration (Idiopathic Hypersomnia Severity Scale), and improved daytime performance.
In August 2021, Xywav became the first and only drug approved for patients with idiopathic hypersomnia by the FDA, and the treatment was made commercially available in November.
Idiopathic hypersomnia is a debilitating neurologic sleep disorder which can severely impact quality of life. It is characterised by EDS, which is the inability to stay awake and alert during the day, resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness.
Yves Dauvilliers, MD, PhD, lead investigator of the study and director of the Sleep and Wake Disorders Centre in the Department of Neurology at the Gui de Chauliac Hospital in Montpellier, France, commented: “The full data set from the largest global Phase III trial in adults with idiopathic hypersomnia represents a major advance in this condition and will enable physicians to make more informed, evidence-driven treatment decisions.
“The trial results demonstrate that Xywav offers significant and clinically meaningful improvements to multiple aspects of this debilitating condition that can benefit the sleep and daily lives of adults diagnosed with this unique sleep disorder.”
Lina Adams
