Avadel Pharmaceuticals (AVDL) said Thursday that Lumryz has been granted Orphan Drug designation by the US Food and Drug Administration to treat idiopathic hypersomnia, a chronic sleep disorder.
The company said the designation was granted because Lumryz may be clinically superior to similar approved drugs due to its once-nightly dosing.
Lumryz is currently being evaluated in a phase 3 trial, which is on track to be completed by the end of 2025, the company said.
Avadel shares were more than 4% higher in premarket trading.
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