(Reuters) -BioXcel Therapeutics plans to seek expanded approval for at-home use of its agitation drug after it met the main goal of a late-stage study in patients with bipolar disorder or schizophrenia, the company said on Wednesday.
Its shares were up nearly 10% in volatile trading before the bell.
The drug, BXCL501, met the main goal of being well-tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia, the company said.
Also known as dexmedetomidine, the drug is sold as Igalmi in the United States for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in medically supervised settings.
The company said it plans to submit the application for expanded approval in the first quarter of 2026.
BioXcel said the unmet medical need in the at-home setting is significant with no FDA-approved treatments and the total addressable market is significantly larger than previously reported.
The trial was designed to evaluate more than 200 patients diagnosed with bipolar disorder or schizophrenia who had experienced episodes of agitation, despite being on prior treatment.
Agitation is common in patients with these neurological disorders and can cause physical or mental unease and excessive motor activity.
All participants in the study lived at home, either alone or with caregivers or informants.
During the 12-week trial, patients either took the approved dose of 120 microgram of BXCL501 or a placebo whenever they experienced agitation.
BXCL501 is the orally dissolving film formulation of dexmedetomidine. It targets receptors in the brain that help reduce stress-related behaviors such as agitation.
(Reporting by Bhanvi Satija, Sneha S K and Siddhi Mahatole in Bengaluru; Editing by Krishna Chandra Eluri and Devika Syamnath)
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