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April 6, 2022

FDA approves BioXcel Therapeutics drug for agitation 

PHOTO | STEVE LASCHEVER BioXcel Therapeutics CEO Vimal Mehta
By Liese Klein

The U.S. Food and Drug Administration (FDA) approved a drug from New Haven-based BioXcel Therapeutics for the treatment of agitation associated with schizophrenia or bipolar disorder in adults, the company announced Wednesday.

The federal regulator ruled that BioXcel’s IGALMI, a single-dose film formulation of dexmedetomidine, was safe and effective for use in acute cases of agitation. The drug is the company’s first FDA-approved product. 

IGALMI, which a patient can self-administer, shows promise as a treatment for the up to 25 million cases of agitation reported a year in the U.S. associated with schizophrenia and bipolar disorder, according to BioXcel. The drug can be taken under the tongue or against the gum. 

BioXcel said it used artificial intelligence to identify dexmedetomidine as a potential treatment for agitation and brought the drug candidate from its first-in-human trials to FDA approval in just under 4 years​.

The company plans to start commercial launch of the product in the current quarter, said BioXcel CEO Vimal Mehta.

“IGALMI is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” Mehta said. “We believe IGALMI has significant market-changing potential.”

BioXcel’s BXCL701, an investigational oral innate immunity activator, has shown early promise as a treatment for a rare and aggressive form of prostate cancer, the company reported in February. 

The company is also working on a potential treatment for agitation in patients with Alzheimer’s disease.

Contact Liese Klein at lklein@newhavenbiz.com.
 

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