BioXcel to seek approval for at-home use of agitation drug after upbeat study
BioXcel Therapeutics (BTAI.O), opens new tab said on Wednesday it plans to seek expanded approval early next year for use of its agitation drug at home after it succeeded in a late-stage study of patients with bipolar disorder or schizophrenia.
The drug, BXCL501 or dexmedetomidine, was well-tolerated in the study comprising more than 200 patients who had agitation episodes despite receiving prior treatment.
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The orally dissolving film form of the drug is sold as Igalmi in the U.S. for treating schizophrenia or bipolar disorder-related agitation with medical supervision.
Early intervention at home can prevent symptom escalation and reduce emergency room visits, CEO Vimal Mehta said. BioXcel is considering partnerships and royalty deals ahead of the drug’s approval and launch, he said.
Shares of the company fell 20%, but analysts said it was not tied to the trial data. The stock has more than doubled in value this month since BioXcel said it plans to report data from the study.
“Today’s decline merely reflects what we would call selling on the news,” said Mizuho analyst Graig Suvannavejh, adding that the company was in a precarious financial situation with cash in hand of $18.6 million as of June 30.
Analysts expect the drug to reach more patients if approved due to the absence of other treatments available at home.
As part of the study, patients, who lived at home either alone or with caregivers, self administered a 120 microgram dose of the drug or a placebo.
They showed improved symptoms and decreased adverse events after repeated dosing over 12 weeks, which was a big unknown about the study, said Rx securities analyst Samir Devani.
BXCL501 targets brain receptors that help reduce stress-related behaviors such as agitation, a common symptom in patients with some neurological disorders that causes physical or mental unease and excessive motor activity.
