The US Food and Drug Administration (FDA) has approved Avadel Pharmaceuticals’ supplemental new drug application for extended-release sodium oxybate (Lumryz) for treatment of cataplexy or excessive daytime sleepiness in children 7 years of age and older with narcolepsy.
The FDA first approved the once-nightly formulation of sodium oxybate for treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy last year, as reported by Medscape Medical News.
“With this label expansion, pediatric patients 7 years and older living with narcolepsy now have the same option that adult patients with narcolepsy have – to choose a once-nightly treatment option that does not disrupt sleep for a middle of the night dose,” Greg Divis, CEO of Avadel Pharmaceuticals, said in a statement.
Narcolepsy is a chronic neurological condition that impairs the brain’s ability to regulate the sleep-wake cycle. The condition affects about 1 in 2000 people in the United States, roughly 5% of whom are children.
Lumryz has a boxed warning as a central nervous system depressant and for its potential for abuse and misuse. The drug is available only through a Risk Evaluation and Mitigation Strategy (REMS) program.
The most common adverse reactions (incidence > 5% than with placebo) reported for any dose of the drug in adults were nausea, dizziness, enuresis, headache, and vomiting. These adverse reactions — as well as decreased weight, decreased appetite, and sleepwalking — were seen in children.
Full prescribing information is available online.