Avadel Pharmaceuticals announces LUMRYZ granted ODD from U.S. FDA

Avadel Pharmaceuticals (AVDL) announced today that LUMRYZ has been granted Orphan Drug Designation, ODD, from the U.S. Food & Drug Administration, FDA, for the treatment of Idiopathic Hypersomnia. Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug 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, a chronic sleep disorder that requires potentially lifelong treatment.