• 19 Mar 2024
• Admin
• News Article

BioXcel Receives European Patent for Sublingual Dexmedetomidine

BioXcel receives European patent for method of treating agitation in dementia using sublingual dexmedetomidine

Overview

BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, reported that the European Patent Office (EPO) granted the company’s European Patent No. 3,562,486 (the “486 patent”) 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.

From CEO: BioXcel Therapeutics

“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, Ph.D., CEO of BioXcel Therapeutics. “The 486 patent aligns with our focus on expanding our patent portfolio for BXCL501 into Europe, and, together with the United States 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.”

US Patents

• 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 United States, the Company currently has eight patents for IGALMI listed in the United States Food and Drug Administration's (FDA) 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 two 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.

IGALMI

IGALMI (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, which is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.

BXCL501

• In indications other than those approved by the US Food and Drug Administration (FDA) as IGALMI (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. 
• BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the company has observed anti-agitation results in multiple clinical trials across several neuropsychiatric disorders.
• BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. 
• The safety and efficacy of BXCL501 for these investigational uses have not been established. 
• BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

BioXcel Therapeutics

BioXcel Therapeutics, Inc. 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.