Positive phase III data for Xywav is published in The Lancet Neurology

The results of the Phase III clinical trial showed clinically meaningful and statistically significant differences with Xywav compared to placebo in the primary endpoint of change in the Epworth Sleepiness Scale (ESS) score and key secondary endpoints, which 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. Xywav for idiopathic hypersomnia was made commercially available in November 2021.

Additionally, the FDA has recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of idiopathic hypersomnia in adults. The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for Xywav for idiopathic hypersomnia began on August 12, 2021, the date of FDA approval for this indication. In June 2021, the FDA recognized seven years of Orphan Drug Exclusivity for Xywav for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy.

Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness, 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. Core symptoms of idiopathic hypersomnia may include confusion, irritability and severe sleep inertia or sleep drunkenness (prolonged difficulty in waking up with frequent reentries into sleep). In addition, people with idiopathic hypersomnia may experience prolonged, non-restorative nighttime sleep, cognitive impairment in thinking, and long and unrefreshing naps.

See-"Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase III, placebo-controlled, double-blind, randomised withdrawal study."-Prof Yves Dauvilliers, MD, Prof Isabelle Arnulf, MD, Prof Nancy Foldvary-Schaefer, DO, Anne Marie Morse, DO, et al. Published;January, 2022DOI:https://doi.org/10.1016/S1474-4422(21)00368-9.