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Investing.com -- BioXcel Therapeutics Inc (NASDAQ:BTAI) stock jumped 23.7% after announcing the completion of its pivotal Phase 3 SERENITY At-Home clinical trial for IGALMI® (dexmedetomidine).
The biopharmaceutical company, which utilizes artificial intelligence to develop neuroscience medicines, reported that the last patient visit has been completed in the study evaluating IGALMI for the treatment of agitation associated with bipolar disorders or schizophrenia in at-home settings. Topline data from the trial is expected to be released this month.
The Phase 3 trial enrolled more than 200 patients across 22 sites nationwide, with a balanced distribution between patients with bipolar disorders and schizophrenia. The double-blind, placebo-controlled study was designed to evaluate the safety of a 120 mcg dose of BXCL501 for acute treatment of agitation.
Results from the study are intended to support BioXcel’s planned supplemental New Drug Application (sNDA) to potentially expand IGALMI’s label for use in outpatient settings.
"This marks a major milestone in our efforts to bring a much-needed at-home treatment option to the millions of individuals who experience agitation related to bipolar disorders or schizophrenia," said Vimal Mehta, CEO of BioXcel Therapeutics.
According to the company, there are approximately 23 million episodes of bipolar or schizophrenia-related agitation annually in the U.S. that occur at home, with no FDA-approved therapies currently available for acute treatment in this setting.
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