Avadel receives FDA Orphan Drug Designation for LUMRYZ for idiopathic hypersomnia

AVADEL PHARMACEUTICALS PLC

• FDA granted Orphan Drug Designation to LUMRYZ (sodium oxybate) for idiopathic hypersomnia (IH).
• If approved, LUMRYZ would qualify for 7-year U.S. market exclusivity, FDA trial design assistance, and fee exemptions.
• LUMRYZ is currently in Phase 3 REVITALYZ trial; enrollment on track to complete by year-end 2025.
• ODD based on clinical superiority hypothesis due to once-nightly dosing, a major contribution to IH patient care.