# US 12,109,196 B2 · Non-sedating dexmedetomidine treatment regimens > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,196 B2 - Document ID: US12109196B2 - Status: Granted - Kind: B2 - Application number: 18/443,689 - Filed: 2024-02-16 - Published: 2024-06-20 - Granted: 2024-10-08 - Earliest claimed: 2019-07-19 - Assignees: BioXcel Therapeutics, Inc. - Applicants: BioXcel Therapeutics, Inc. - Inventors: Vasukumar Kakumanu; David Christian Hanley; Frank Yocca; Chetan Dalpatbhai Lathia; Lavanya Rajachandran; Robert Risinger - Web page: https://patentgrep.com/patent/US12109196B2 ## 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 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 9/2013: {Organic compounds, e.g. phospholipids, fats} - A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates} - A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)} - A61K 9/7015: {Drug-containing film-forming compositions, e.g. spray-on} - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) - A61K 47/38: Cellulose; Derivatives thereof - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia - A61P 25/20: Hypnotics; Sedatives - A61P 25/36: Opioid-abuse - 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 Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium. ## Claims ### Claim 1 A method of treating an agitation of a human subject in need thereof using an oromucosal formulation of dexmedetomidine or a pharmaceutically acceptable salt thereof, the method comprising: administering a first dose of the oromucosal formulation of dexmedetomidine or a pharmaceutically acceptable salt thereof to the human subject, wherein the first dose is 60 mcg, 80 mcg, 90 mcg, 120 mcg, or 180 mcg of dexmedetomidine; and, after at least two hours, administering a second dose of the oromucosal formulation of dexmedetomidine or a pharmaceutically acceptable salt thereof to the human subject, and wherein the second dose is 40 mcg, 60 mcg, 80 mcg, 90 mcg, or 120 mcg of dexmedetomidine; and wherein the human subject has a corrected QT interval using Fridericia's correction method (QTcF) of no greater than 450 msec for males and no greater than 470 msec for females. ### Claim 2 (depends on 1) The method of claim 1, wherein the initial dose is 60 mcg or 120 mcg. ### Claim 3 (depends on 1) The method of claim 1, wherein the second dose is 60 mcg or 120 mcg. ### Claim 4 (depends on 1) The method of claim 1, wherein the agitation is associated schizophrenia or bipolar disorders. ### Claim 5 (depends on 4) The method of claim 4, wherein the first dose is 120 mcg and the second dose is 120 mcg. ### Claim 6 (depends on 5) The method of claim 5, wherein the second dose is administered at least 4 hours after the first dose. ### Claim 7 (depends on 6) The method of claim 6, wherein the second dose is administered at least 6 hours after the first dose. ### Claim 8 (depends on 6) The method of claim 6, wherein the second dose is administered at least 8 hours after the first dose. ### Claim 9 (depends on 6) The method of claim 6, wherein the second dose is administered at least 10 hours after the first dose. ### Claim 10 (depends on 6) The method of claim 6, wherein the second dose is administered at least 12 hours after the first dose. ### Claim 11 (depends on 6) The method of claim 6, wherein the second dose is administered at least 14 hours after the first dose. ### Claim 12 (depends on 6) The method of claim 6, wherein the second dose is administered at least 16 hours after the first dose. ### Claim 13 (depends on 6) The method of claim 6, wherein the second dose is administered at least 18 hours after the first dose. ### Claim 14 (depends on 6) The method of claim 6, wherein the second dose is administered at least 20 hours after the first dose. ### Claim 15 (depends on 1) The method of claim 1, wherein the agitation is associated dementia. ### Claim 16 (depends on 15) The method of claim 15, wherein the first dose is 60 mcg and the second dose is 60 mcg. ### Claim 17 (depends on 16) The method of claim 16, wherein the second dose is administered at least 4 hours after the first dose. ### Claim 18 (depends on 17) The method of claim 17, wherein the second dose is administered at least 6 hours after the first dose. ### Claim 19 (depends on 17) The method of claim 17, wherein the second dose is administered at least 8 hours after the first dose. ### Claim 20 (depends on 17) The method of claim 17, wherein the second dose is administered at least 10 hours after the first dose. ### Claim 21 (depends on 17) The method of claim 17, wherein the second dose is administered at least 12 hours after the first dose. ### Claim 22 (depends on 17) The method of claim 17, wherein the second dose is administered at least 14 hours after the first dose. ### Claim 23 (depends on 17) The method of claim 17, wherein the second dose is administered at least 16 hours after the first dose. ### Claim 24 (depends on 17) The method of claim 17, wherein the second dose is administered at least 18 hours after the first dose. ### Claim 25 (depends on 17) The method of claim 17, wherein the second dose is administered at least 20 hours after the first dose.