Alkermes' Alixorexton Gets Orphan Drug Designation in U.S. and Europe

Alkermes plc announced that its investigational drug, alixorexton, has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia and the European Commission for the treatment of narcolepsy. Alixorexton is an oral, selective orexin 2 receptor agonist currently in development for narcolepsy types 1 and 2, and idiopathic hypersomnia. This designation provides incentives for the development of treatments for rare diseases and offers potential market exclusivity if the drug is approved.