Avadel Pharma Says FDA Grants Orphan Drug Designation For LUMRYZ To Treat Idiopathic Hypersomnia

(RTTNews) - Biopharmaceutical company Avadel Pharmaceuticals plc (AVDL) announced Thursday that LUMRYZ has been granted Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH).

This was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, because LUMRYZ may provide a major contribution to patient care due to its once-nightly dosing for patients with IH.

IH is a rare and debilitating chronic sleep disorder characterized by excessive daytime sleepiness not attributable to any other medical conditions that requires potentially lifelong treatment.

LUMRYZ is currently being evaluated for the treatment of IH in the REVITALYZ trial, which is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ when given as a once-at-bedtime dose.

The study will enroll approximately 150 adults who are diagnosed with IH. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates as well as those not currently taking oxybates, and is on track to be completed by year end 2025.