The US Food and Drug Administration (FDA) has approved dexmedetomidine (Igalmi, BioXcel Therapeutics) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120 μg and 180 μg doses.
An estimated 7.3 million individuals in the US are diagnosed with schizophrenia or bipolar disorders, and up to one quarter of them experience episodes of agitation that can occur 10 to 17 times annually. These episodes represent a significant burden for patients, caregivers, and the healthcare system.
"There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for healthcare professionals to treat," said John Krystal, MD, the Robert L. McNeil, Jr, Professor of Translational Research and chair of the Department of Psychiatry at Yale School of Medicine.
"The approval of Igalmi, a self-administered film with a desirable onset of action, represents a milestone moment. It provides healthcare teams with an innovative tool to help control agitation.
