NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical firm leveraging artificial intelligence in drug development, announced the granting of a European patent for its dexmedetomidine treatment for agitation in dementia patients. The European Patent Office issued Patent No. 3,562,486 on March 13, 2024, covering a range of sublingual dosage forms, such as films, wafers, and tablets.
The patent is a significant addition to BioXcel's intellectual property portfolio, which includes over 100 patent applications under prosecution and multiple issued patents. "The 486 patent aligns with our focus on expanding our patent portfolio for BXCL501 into Europe," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. The company believes this strengthens their foundation for potential commercialization in various geographies, pending approval.
This European patent follows the recent allowance of a U.S. patent application for the treatment of agitation in Alzheimer's disease patients using a water-soluble oromucosal administration of dexmedetomidine. The U.S. Patent and Trademark Office also allowed a patent application for a method of treating agitation with an oromucosal formulation of dexmedetomidine, which is expected to extend protection for the company's IGALMI™ sublingual film until January 12, 2043.
IGALMI™ is currently approved for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. It is administered under healthcare provider supervision, and its safety and efficacy beyond 24 hours from the initial dose have not been studied. The most common side effects reported in clinical trials include sleepiness, dizziness, and low blood pressure.
BioXcel's BXCL501 is an investigational film formulation of dexmedetomidine, targeting agitation across several neuropsychiatric disorders. It has received Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for treating agitation related to schizophrenia, bipolar disorders, and dementia.
The information in this article is based on a press release statement from BioXcel Therapeutics.
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