India, June 5 -- 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.
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