FDA Approves First Sublingual Medication for Agitation in Serious Mental Illness
The FDA approved dexmedetomidine (Igalmi) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication and the first new acute treatment for schizophrenia or bipolar disorder–associated agitation in nearly a decade.
In two pivotal randomized, double-blinded, placebo-controlled, parallel-group phase 3 clinical trials of dexmedetomidine sublingual film, the medication was shown to rapidly relieve mild to moderate acute agitation in patients as soon as 20 minutes. Both doses of the film (120 mcg and 180 mcg) showed a high response rate in patients.
The most common adverse reactions were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity.
Dexmedetomidine sublingual film is a product of BioXcel Therapeutics.