The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals’ sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.
Shares of Avadel rose 3.5% to $13.70 in early morning trade.
The company said on Thursday the drug, called Lumryz, was now approved to treat pediatric patients with sudden muscle weakness called cataplexy or for excessive daytime sleepiness (EDS), both symptoms of narcolepsy. It was approved for adults in 2023.
Narcolepsy is a chronic neurological disorder that impacts the brain’s ability to regulate sleep and wake cycles, with 70% of patients also experiencing cataplexy.
Dosed once a night, Lumryz competes with twice-nightly drugs such as Jazz Pharmaceuticals’ Xyrem and Xywav.
(Reporting by Unnamalai L and Christy Santhosh in Bengaluru; Editing by Devika Syamnath)
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