FDA approves dexmedetomidine as a drug for treatment of schizophrenia, bipolar disorder

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.

Researchers concluded that Igalmi is the first new acute treatment for schizophrenia or bipolar disorder associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom, 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.

Reference: https://clinicaltrials.gov/ct2/show/NCT04276883