Alkermes Granted Orphan Drug Designations for Alixorexton in US, Europe
The investigational oral orexin 2 receptor agonist received designations from the FDA for idiopathic hypersomnia and the European Commission for narcolepsy.
The investigational oral orexin 2 receptor agonist received designations from the FDA for idiopathic hypersomnia and the European Commission for narcolepsy.
The crossover dose optimization study aims to refine the dosing profile of the oral therapy and strengthen the design of the planned phase III development program.
It will analyze once-daily and split-dose regimens of the oral orexin 2 receptor agonist in people with narcolepsy type 1 and type 2.
Retrospective questionnaires may miss the true impact of treatments on symptoms such as daytime functioning.
Findings reveal a high reliance on cannabis for sleep onset among adults aged 19 to 30, prompting calls for better clinical screening regarding substance use.
Topline results from the exploratory trial indicate the aldosterone synthase inhibitor did not reduce the apnea-hypopnea index but provided clinically meaningful blood pressure reduction in adults with moderate-to-severe OSA and hypertension.