FDA to rule on BioXcel’s first drug by January 2022
PHOTO | STEVE LASCHEVER
BioXcel Therapeutics CEO Vimal Mehta
New Haven’s BioXcel Therapeutics took a major step forward this week in its push to bring its first commercial drug to the marketplace.
The company, which uses artificial intelligence for drug discovery, learned Tuesday that the Food and Drug Administration has accepted its new drug application (NDA) for BXCL501, kicking off a months-long review by the agency.
The FDA set a Jan. 5, 2022 deadline to decide on the drug, which treats acute agitation in patients with schizophrenia and bipolar disorder.
“The filing of our NDA marks an important milestone toward our goal to provide a new treatment option for the millions of patients with schizophrenia and bipolar disorders struggling with acute agitation,” said CEO Vimal Mehta.
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.
BioXcel discovered the drug using its AI platform and repurposed it to treat agitation, a practice that allowed the company to save time in what is typically a lengthy regulatory approval process. The intravenous version of the drug had previously been used as an operating room sedative.
BioXcel’s Phase 3 clinical trial of BXCL501 found patients experienced a statistically significant improvement in agitation two hours after taking it, according to data released last summer, and that it started working in as little as 20 minutes.
The company said the drug would provide a non-invasive and less sedating way to calm the more than 3 million schizophrenia and bipolar patients who experience agitation episodes in the U.S. each year.
“We believe that BXCL501, if approved, would represent a significant improvement in the care and management of agitation in these patients, potentially easing the burden for physicians and allied caregivers,” Mehta said.
He said the company will spend the coming months executing a comprehensive commercial strategy to position itself for the drug’s potential approval next year.
Contact Natalie Missakian at news@newhavenbiz.com
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