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The treatment represents the only FDA approved orally dissolving sublingual film for this patient population.
The US Food and Drug Administration (FDA) has approved dexmedetomidine (IGALMI) sublingual film for the acute treatment of adult patients with agitation associated with schizophrenia or bipolar I or II disorders.
The approval, awarded to BioXcel Therapeutics, represents the first and only FDA-approved orally dissolving sublingual film for the psychiatric disorders. The treatment can be self-administered by patients under the supervision of a healthcare provider.
Agitation is a symptom within this patient population that leads to significant burden for the individual, as well as for caregivers and the overall healthcare system.
The approval is based on the results of a pair of pivotal, randomized, double-blinded, placebo-controlled, parallel group phase 3 trials evaluating the treatment in patients with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).
The investigators sought primary endpoints of the mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score assessed 2 hours following dosing.
They also looked at secondary endpoints of the earliest time where efficacy, measured by the change from baseline in PEC scores, was statistically separated from placebo.
The treatment met the primary endpoint in both trials 2 hours after the first dose in patients treated with the 120 mcg and 180 mcg doses. This shows a rapid onset of action with statistically significant separation from placebo identified at 20 minutes for both doses in the SERENITY II trial and at 20 minutes for 180 mcg and 30 minutes for 120 mcg doses in SERENITY I.
For safety, the most common adverse reactions, all of which were mild to moderate in severity, found in the treatment group were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.
“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 Dr. John Krystal, MD, the Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Department of Psychiatry at Yale School of Medicine, in a statement. “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. As clinicians, we welcome this much-needed new oral treatment option.”
BioXcel expects the treatment to be available in the US in the second quarter of 2022.