Igalmi FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 10, 2022.
FDA Approved: Yes (First approved April 5, 2022)
Brand name: Igalmi
Generic name: dexmedetomidine
Dosage form: Sublingual Film
Company: BioXcel Therapeutics, Inc.
Treatment for: Agitation
Igalmi (dexmedetomidine) is a sublingual film formulation of the approved alpha2-adrenergic receptor agonist dexmedetomidine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
- Dexmedetomidine was first approved in injection form under the brand name Precedex in 1999 for the sedation of ventilated patients in intensive care.
- Igalmi should be administered under the supervision of a healthcare provider, who will monitor vital signs and alertness to prevent falls and syncope.
- Igalmi sublingual film is for sublingual or buccal administration, and should not be chewed or swallowed. Patients should not not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration.
- Warnings and precautions associated with Igalmi include hypotension, orthostatic hypotension, and bradycardia; QT interval prolongation; and somnolence.
- Common adverse reactions include somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.
Development timeline for Igalmi
Further information
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