BioXcel Therapeutics Announces European Patent Office’s Grant of Patent for Method of Treating Agitation in Dementia Using Sublingual Dexmedetomidine

BioXcel Therapeutics, Inc. recently reported the European Patent Office (EPO) granted the company’s European Patent No. 3,562,486 on March 13, 2024. The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia. The patent encompasses a broad range of dosage forms, including films, such as BXCL501 (sublingual dexmedetomidine), wafers, and tablets, at dexmedetomidine doses ranging from 3 mcg to 100 mcg.

“We have made great progress in building our intellectual property portfolio, with more than 100 patent applications in prosecution and multiple patents issued to date,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics. “The 486 patent aligns with our focus on expanding our patent portfolio for BXCL501 into Europe, and, together with the US and Japan, extends our BXCL501 franchise patent protection to three major markets. We believe this represents a strong foundation to potentially expand our commercialization of BXCL501 into additional geographies, if approved.”

The 486 patent comes on the heels of the US Patent and Trademark Office (USPTO) recently allowing US Patent Application No. 17/496,470 with claims pertaining to methods of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers.

Additionally, in the US, the company currently has eight patents for IGALMI listed in the US FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). The company also received notice that the USPTO has allowed US Patent Application No. 18/216,890 with claims pertaining to a method of treating agitation using an oromucosal formulation of dexmedetomidine or a pharmaceutically acceptable salt thereof through the administration of an initial dose of 60 mcg, 80 mcg, 90 mcg, 120 mcg or 180 mcg of dexmedetomidine and, after at least 2 hours, administering an oromucosal formulation of dexmedetomidine or a pharmaceutically acceptable salt thereof in a second dose of 40 mcg, 60 mcg, 80 mcg or 90 mcg of dexmedetomidine, where the patient has a QT interval of less than 470 msec. The patent, when issued, is expected to have an expiration date of July 17, 2040, subject to patent term adjustment, patent term extension, and terminal disclaimers. The company expects that this patent, when issued, will be submitted for listing in the Orange Book with the eight currently listed US patents for IGALMI (dexmedetomidine) sublingual film. Collectively, these nine patents will in general extend patent protection for IGALMI until January 12, 2043.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications.  For more information, visit bioxceltherapeutics.com.