AVADEL PHARMACEUTICALS PLC

Avadel Pharmaceuticals plc is a biopharmaceutical company. Its sole commercial product is LUMRYZ, an extended-release formulation of sodium oxybate. LUMRYZ is indicated for once-at-bedtime treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. The U.S. Food and Drug Administration (FDA) approved LUMRYZ on May 1, 2023, for treating cataplexy or EDS in adults with narcolepsy. The FDA granted seven years of Orphan Drug Exclusivity (ODE) for this indication, lasting until May 1, 2030, based on LUMRYZ's clinical superiority over existing oxybate treatments due to its once-nightly dosing regimen. Avadel announced the U.S. commercial launch of LUMRYZ for adults with narcolepsy in June 2023. On October 16, 2024, the FDA approved LUMRYZ for treating cataplexy or EDS in the pediatric narcolepsy population aged seven years and older, granting ODE for this group through October 16, 2031. The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for LUMRYZ to manage risks associated with inappropriate prescribing, misuse, abuse, and diversion.