Avadel Pharmaceuticals’ Narcolepsy Drug LUMRYZ Receives FDA Approval and Orphan Drug Exclusivity

FDA Approval:
LUMRYZ (sodium oxybate) received final FDA approval on May 1, 2023, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Orphan Drug Exclusivity:
The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity, which began on May 1, 2023, due to its clinical superiority over twice-nightly oxybate products.

Product Availability:
LUMRYZ became commercially available in early June 2023, following its approval.

Clinical Superiority:
The FDA found LUMRYZ to be clinically superior to currently marketed twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal for a second dose.

REMS Program:
LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to its potential for abuse and misuse.

Pivotal Phase 3 Trial:
The approval was supported by positive results from the REST-ON clinical trial, which demonstrated statistically significant and clinically meaningful improvements in EDS, clinicians’ overall assessment of patients’ functioning, and cataplexy attacks.