Claims for Patent: 11,998,528

Summary for Patent: 11,998,528

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:	US18/189,073
Patent Claims:	1. A method of treating acute agitation associated with schizophrenia or bipolar disorder in an agitated human subject at risk of torsades de pointes or sudden death, comprising: administering dexmedetomidine or a pharmaceutically acceptable salt thereof in an oromucosal formulation up to a maximum dosing regimen; wherein the maximum dosing regimen is a single dose of 120 mcg of dexmedetomidine when a maximum allowed QT prolongation is less than 7 msec; wherein the maximum dosing regimen is a single dose of 120 mcg of dexmedetomidine plus 1 or 2 additional doses of 60 mcg at least 2 hours apart when a maximum allowed QT prolongation is less than 9 msec but no less than 7 msec; wherein the maximum dosing regimen is a single dose of 180 mcg of dexmedetomidine when a maximum allowed QT prolongation is less than 11 msec but no less than 9 msec; and wherein the maximum dosing regimen is a single dose of 180 mcg of dexmedetomidine plus 1 or 2 additional doses of 90 mcg at least 2 hours apart when a maximum allowed QT prolongation is less than 14 msec but no less than 11 msec. 2. The method of claim 1, wherein the maximum allowed QT prolongation is further based on at least one risk factor for the risk of torsades de pointes or sudden death. 3. The method of claim 2, wherein the at least one risk factor is a known QT prolongation of the agitated human subject. 4. The method of claim 2, wherein the at least one risk factor is a history of other arrhythmias of the agitated human subject. 5. The method of claim 2, wherein the at least one risk factor is a symptomatic bradycardia of the agitated human subject. 6. The method of claim 2, wherein the at least one risk factor is a hypokalemia of the agitated human subject. 7. The method of claim 2, wherein the at least one risk factor is a hypomagnesemia of the agitated human subject. 8. The method of claim 2, wherein the at least one risk factor is additional drugs that prolong the QT interval of the agitated human subject. 9. The method of claim 3, wherein the at least one risk factor comprises a history of other arrhythmias, a symptomatic bradycardia, hypokalemia or hypomagnesemia, and additional drugs known to prolong the QT interval of the agitated human subject. 10. A method of treating acute agitation associated with schizophrenia or bipolar disorder in an agitated human subject at risk of torsades de pointes or sudden death, comprising: administering dexmedetomidine or a pharmaceutically acceptable salt thereof in an oromucosal formulation up to a maximum dosing regimen; wherein the maximum dosing regimen is a single dose of 120 mcg of dexmedetomidine when a maximum allowed QT prolongation is less than 6 msec; wherein the maximum dosing regimen is a single dose of 120 mcg of dexmedetomidine plus 1 or 2 additional doses of 60 mcg at least 2 hours apart when a maximum allowed QT prolongation is less than 8 msec but no less than 6 msec; wherein the maximum dosing regimen is a single dose of 180 mcg of dexmedetomidine when a maximum allowed QT prolongation is less than 8 msec but no less than 6 msec; and wherein the maximum dosing regimen is a single dose of 180 mcg of dexmedetomidine plus 1 or 2 additional doses of 90 mcg at least 2 hours apart when a maximum allowed QT prolongation is less than 11 msec but no less than 8 msec. 11. The method of claim 10, wherein the maximum allowed QT prolongation of the agitated human subject is further based on at least one risk factor for the risk of torsades de pointes or sudden death. 12. The method of claim 11, wherein the at least one risk factor is a known QT prolongation of the agitated human subject. 13. The method of claim 11, wherein the at least one risk factor is a history of other arrhythmias of the agitated human subject. 14. The method of claim 11, wherein the at least one risk factor is a symptomatic bradycardia of the agitated human subject. 15. The method of claim 11, wherein the at least one risk factor is a hypokalemia of the agitated human subject. 16. The method of claim 11, wherein the at least one risk factor is a hypomagnesemia of the agitated human subject. 17. The method of claim 11, wherein the at least one risk factor is additional drugs that prolong the QT interval of the agitated human subject. 18. The method of claim 12, wherein the at least one risk factor comprises a history of other arrhythmias, a symptomatic bradycardia, hypokalemia or hypomagnesemia, and additional drugs that prolong the QT interval of the agitated human subject.