Claims for Patent: 12,109,196

Summary for Patent: 12,109,196

Title:	Non-sedating dexmedetomidine treatment regimens
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.
Inventor(s):	Vasukumar KAKUMANU, David Christian HANLEY, Frank Yocca, Chetan Dalpatbhai LATHIA, Lavanya Rajachandran, Robert Risinger
Assignee:	Bioxcel Therapeutics Inc
Application Number:	US18/443,689
Patent Claims:	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. 2. The method of claim 1, wherein the initial dose is 60 mcg or 120 mcg. 3. The method of claim 1, wherein the second dose is 60 mcg or 120 mcg. 4. The method of claim 1, wherein the agitation is associated schizophrenia or bipolar disorders. 5. The method of claim 4, wherein the first dose is 120 mcg and the second dose is 120 mcg. 6. The method of claim 5, wherein the second dose is administered at least 4 hours after the first dose. 7. The method of claim 6, wherein the second dose is administered at least 6 hours after the first dose. 8. The method of claim 6, wherein the second dose is administered at least 8 hours after the first dose. 9. The method of claim 6, wherein the second dose is administered at least 10 hours after the first dose. 10. The method of claim 6, wherein the second dose is administered at least 12 hours after the first dose. 11. The method of claim 6, wherein the second dose is administered at least 14 hours after the first dose. 12. The method of claim 6, wherein the second dose is administered at least 16 hours after the first dose. 13. The method of claim 6, wherein the second dose is administered at least 18 hours after the first dose. 14. The method of claim 6, wherein the second dose is administered at least 20 hours after the first dose. 15. The method of claim 1, wherein the agitation is associated dementia. 16. The method of claim 15, wherein the first dose is 60 mcg and the second dose is 60 mcg. 17. The method of claim 16, wherein the second dose is administered at least 4 hours after the first dose. 18. The method of claim 17, wherein the second dose is administered at least 6 hours after the first dose. 19. The method of claim 17, wherein the second dose is administered at least 8 hours after the first dose. 20. The method of claim 17, wherein the second dose is administered at least 10 hours after the first dose. 21. The method of claim 17, wherein the second dose is administered at least 12 hours after the first dose. 22. The method of claim 17, wherein the second dose is administered at least 14 hours after the first dose. 23. The method of claim 17, wherein the second dose is administered at least 16 hours after the first dose. 24. The method of claim 17, wherein the second dose is administered at least 18 hours after the first dose. 25. The method of claim 17, wherein the second dose is administered at least 20 hours after the first dose.