Avadel Pharma's SNDA For Lumryz Gets FDA Approval

(RTTNews) - Biopharmaceutical company Avadel Pharmaceuticals plc (AVDL), Thursday announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.

"This approval represents an important milestone for the narcolepsy community, specifically for younger narcolepsy patients and their caregivers who face significant challenges associated with waking up in the middle of the night to complete treatment regimens. 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," said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.

Narcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. The condition affects approximately 1 in 2,000 people in the United States, where roughly 5% of patients are under the age of 18.

Lumryz is a once-at-bedtime formulation extended-release sodium oxybate and was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy.