Avadel Pharmaceuticals announces FDA approval of sNDA for LUMRYZ

Avadel Pharmaceuticals announced that the U.S. Food and Drug Administration 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. 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. LUMRYZ was approved by the FDA for use in the treatment of cataplexy or EDS in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity through October 16, 2031.