Avadel's narcolepsy drug Lumryz gets USFDA approval for pediatric use
Avadel's drug contains a central nervous system depressant drug called sodium oxybate, which helps increase the amount of time someone spends in deep sleep.
Bengaluru: The U.S. Food and Drug Administration has granted approval for Avadel Pharmaceuticals' sleep disorder drug to be used in children aged 7 and older, expanding its application and intensifying competition with Jazz Pharmaceuticals' leading treatments.
Avadel 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.
Lumryz's main area of differentiation from Jazz Pharma's Xyrem and Xywav is its once-nightly dosing that eliminates the need to wake up in the middle of the night, Needham analyst Ami Fadia said.
Avadel's drug contains a central nervous system depressant drug called sodium oxybate, which helps increase the amount of time someone spends in deep sleep. Children make up about 5% of the current oxybate-treated population.
Jefferies expects peak annual sales of $550 million to $1 billion from Lumryz, with the pediatric approval expected to add another $50 to $100 million.
While Jazz's sleep disorder drugs are approved for the same condition as Lumryz, Xywav has the FDA's expanded nod to treat idiopathic hypersomnia, a rare neurological condition that causes excessive sleepiness.
Last year, Jazz brought in $569.7 million in Xyrem sales and $1.27 billion from Xywav. Lumryz, launched over a year ago, brought about $28 million for Avadel.
Lumryz comes with a boxed warning for reduced stimulation of the central nervous system, and for its potential for abuse and misuse.
The FDA's decision on Lumryz was expected in September, but it was extended after the health regulator said the drug was still under review.
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