FDA green light for BioXcel's Igalmi

6 April 2022

The US Food and Drug Administration has just approved Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia and bipolar I or II disorders in adults. The drug was developed by Connecticut, USA company BioXcel Therapeutics (Nasdaq: BTAI), whose shares gained 4.6% to $20.78 in mid-morning trading today

The safety and effectiveness of Igalmi has not been established beyond 24 hours from the first dose. Igalmi, a proprietary, single-dose, sublingual film formulation of dexmedetomidine, is the first approved product for BioXcel and the first medication approved by the FDA for this use in almost a decade.

As background, the company notes:

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