The Food and Drug Administration (FDA) has approved Igalmi™ (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Igalmi is an orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist, intended for sublingual or buccal administration under the supervision of a health care provider. The safety and efficacy of Igalmi have not been established beyond 24 hours from the first dose.
The approval was based on data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I (ClinicalTrials.gov Identifier: NCT04268303) and II (ClinicalTrials.gov Identifier: NCT04276883) studies, which evaluated the efficacy and safety of Igalmi for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively. Patients were randomly assigned to receive a single dose of Igalmi 120mcg, Igalmi 180mcg, or placebo.
Results from both studies showed that Igalmi met the primary endpoint achieving statistically significant and clinically meaningful reductions in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) score at 2 hours vs placebo (P <.0001). A statistically significant decrease in agitation was observed with Igalmi beginning at 20 minutes after the 180mcg dose and 30 minutes after the 120mcg dose in SERENITY I, and at 20 minutes after both the 120mcg and 180mcg doses in SERENITY II.
The most common adverse reactions reported for Igalmi were somnolence, paresthesia, oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. Igalmi should be avoided in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope.
Igalmi is supplied as a sublingual film containing 120mcg and 180mcg of dexmedetomidine in foil pouches. The dosage for Igalmi is based on agitation severity with a lower dose recommended for patients with hepatic impairment and geriatric patients. If agitation persists after the initial dose of Igalmi, up to 2 additional doses may be administered at least 2 hours apart.
The product is expected to be available in the second quarter of 2022.
- BioXcel Therapeutics announces FDA approval of Igalmi™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. News release. BioXcel Therapeutics. Accessed April 6, 2022. https://www.globenewswire.com/news-release/2022/04/06/2417422/0/en/BioXcel-Therapeutics-Announces-FDA-Approval-of-IGALMI-dexmedetomidine-Sublingual-Film-for-Acute-Treatment-of-Agitation-Associated-with-Schizophrenia-or-Bipolar-I-or-II-Disorder-in-.html
- Igalmi. Package insert. BioXcel Therapeutics; 2022. Accessed April 6, 2022. https://igalmihcp.com/igalmi-pi.pdf