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March 16, 2021

BioXcel drug named “breakthrough therapy” for dementia agitation

PHOTO | CONTRIBUTED BioXcel CEO Vimal Mehta
By Natalie Missakian

The Food and Drug Administration has designated a BioXcel Therapeutics drug a “breakthrough therapy” for dementia-related agitation, a label that has the potential to speed up the regulatory review process.

The FDA reserves the designation for potential medicines that treat a serious or life threatening condition and offer a substantial improvement over existing treatments.

In addition to an expedited review timeline, companies developing breakthrough drugs qualify for more intensive guidance and more frequent interactions with the FDA.

BioXcel said the FDA based its decision on positive topline data from a recent Phase 1b/2 clinical trial showing statistically significant reductions in agitation in patients two hours after taking the drug. 

CEO Vimal Mehta said it “further underscores the significant unmet need for a new treatment for this underserved patient population.” 

The drug, BXCL501, is a thin-film formulation of an older drug known as “Dex” (dexmedetomidine). It tastes minty and dissolves in the mouth, similar to a mouthwash strip.

Meanwhile last week, BioXcel said it filed its first new drug application (NDA) with the FDA for approval of the drug to treat agitation in patients with schizophrenia and bipolar disorder.

The FDA has 60 days to determine whether to file or reject the NDA. If accepted, the drug would be on track for FDA approval by early 2022.

Contact Natalie Missakian at news@newhavenbiz.com

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