# US 2022/0031663 A1 · Use of sublingual dexmedetomidine for the treatment of agitation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2022/0031663 A1 - Document ID: US20220031663A1 - Status: Published application - Kind: A1 - Application number: 17/496,470 - Filed: 2021-10-07 - Published: 2022-02-03 - Earliest claimed: 2016-12-31 - Assignees: BioXcel Therapeutics, Inc. - Applicants: BioXcel Therapeutics, Inc. - Inventors: Krishnan NANDABALAN; Frank YOCCA; Sameer SHARMA - Web page: https://patentgrep.com/patent/US20220031663A1 ## CPC - A61K 31/4174: Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole - A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays} - A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61P 25/00: Drugs for disorders of the nervous system - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation. ## Claims ### Claim 1 A method of treating agitation in an agitated subject comprising administering to the oral mucosa of said subject an effective amount of dexmedetomidine or a pharmaceutically acceptable salt thereof without also causing significant sedation within about 60 minutes after the administration, wherein the subject has dementia. ### Claim 2 (depends on 1) The method according to claim 1, wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered in a dosage form selected from the group consisting of a film, a wafer, a patch, a lozenge, a gel, a spray, a tablet, and a liquid drop. ### Claim 3 (depends on 1) The method according to claim 1, wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered at a dosage in the range of about 3 micrograms to about 100 micrograms. ### Claim 4 (depends on 3) The method according to claim 3, wherein said dosage is about 5 micrograms to about 90 micrograms. ### Claim 5 (depends on 4) The method according to claim 4, wherein the dosage is about 5 micrograms to about 60 micrograms. ### Claim 6 (depends on 4) The method according to claim 4, wherein the dosage is about 5 micrograms to about 50 micrograms. ### Claim 7 (depends on 4) The method according to claim 4, wherein the dosage is about 5 micrograms to about 45 micrograms. ### Claim 8 (depends on 4) The method according to claim 4, wherein the dosage is about 5 micrograms to about 40 micrograms. ### Claim 9 (depends on 4) The method according to claim 4, wherein the dosage is about 30 micrograms. ### Claim 10 (depends on 4) The method according to claim 4, wherein the dosage is about 40 micrograms. ### Claim 11 (depends on 4) The method according to claim 4, wherein the dosage is about 50 micrograms. ### Claim 12 (depends on 4) The method according to claim 4, wherein the dosage is about 60 micrograms. ### Claim 13 (depends on 4) The method according to claim 4, wherein the dosage is about 90 micrograms. ### Claim 14 (depends on 1) The method according to claim 1, wherein the agitation is acute agitation. ### Claim 15 (depends on 1) The method according to claim 1, wherein the agitation is chronic agitation. ### Claim 16 (depends on 1) The method according to claim 1, wherein the agitation is severe agitation. ### Claim 17 (depends on 2) The method according to claim 2, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is administered sublingually. ### Claim 18 (depends on 17) The method according to claim 17, wherein the dosage form is a film. ### Claim 19 (depends on 18) The method according to claim 18, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride. ### Claim 20 (depends on 2) The method according to claim 2, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is administered buccally. ### Claim 21 (depends on 20) The method according to claim 20, wherein the dosage form is a film. ### Claim 22 (depends on 22) The method according to claim 22, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride. ### Claim 23 A method of treating agitation in an agitated dementia subject comprising administering dexmedetomidine to the subject; wherein the dosage is about 5 micrograms to about 90 micrograms; wherein the dosage form is a film, and wherein the film is administered to the oral mucosa. ### Claim 24 (depends on 23) The method of claim 23, wherein the film is administered sub-lingually. ### Claim 25 (depends on 23) The method of claim 23, wherein the film is administered buccally.