The U.S. Food and Drug Administration (FDA) has approved Avadel Pharmaceuticals’ drug, Lumryz, for treating sleep disorders in children aged 7 and older. This approval expands the drug’s use, intensifying competition with Jazz Pharmaceuticals’ treatments.
On Thursday, Avadel announced that Lumryz is now authorized for pediatric patients experiencing cataplexy, a sudden muscle weakness, and excessive daytime sleepiness (EDS), both symptoms of narcolepsy. The drug was previously approved for adults in 2023. Narcolepsy is a chronic neurological disorder affecting sleep regulation, with around 70% of patients also experiencing cataplexy.
Analyst Ami Fadia from Needham noted that Lumryz stands out due to its once-nightly dosing, which eliminates nighttime awakenings, unlike Jazz Pharma’s Xyrem and Xywav. Lumryz contains sodium oxybate, a central nervous system depressant that helps improve deep sleep. Currently, children make up about 5% of the oxybate-treated population.
Jefferies projects that Lumryz could generate peak annual sales between $550 million and $1 billion, with pediatric approval potentially adding $50 to $100 million.
While Jazz’s sleep disorder drugs treat the same conditions, Xywav has FDA approval for idiopathic hypersomnia, a rare condition causing excessive sleepiness. Last year, Jazz reported $569.7 million in Xyrem sales and $1.27 billion from Xywav. Lumryz, launched over a year ago, generated approximately $28 million for Avadel.
Lumryz carries a boxed warning due to its potential for central nervous system depression and risk of abuse. Following the FDA’s announcement, Avadel’s shares rose 1.4% to $13.43. The FDA’s decision, initially expected in September, was delayed as the drug remained under review.
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