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BioXcel Gets First Approval With Igalmi For Neuropsychiatric Agitation

 
• By Joseph Haas

Sublingual film product Igalmi is approved to treat agitation related to schizophrenia and bipolar disorder, but BioXcel also is targeting a bigger market opportunity in Alzheimer’s dementia.

Anxiety
BioXcel's new sublingual film can address anxiety in psychiatric patients • Source: Alamy

With its first approved product, BioXcel Therapeutics, Inc. believes it has a differentiated treatment for agitation in schizophrenia and bipolar disorder patients, but the US Food and Drug Administration approval of Igalmi (BXCL501) announced on 6 April could be a way station on the path to bigger market opportunities for the sublingual film product in dementia and depression.

Igalmi, a thin, orally dissolving formulation of dexmedetomidine, obtained approval for mild, moderate and severe agitation in patients with schizophrenia or bipolar I or II disorders. Although the product can...

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