US 12,364,683 B2
Non-sedating dexmedetomidine treatment regimens
Vasukumar Kakumanu, New Haven, CT (US); David Christian Hanley, New Haven, CT (US); Frank Yocca, New Haven, CT (US); Chetan Dalpatbhai Lathia, New Haven, CT (US); Lavanya Rajachandran, New Haven, CT (US); and Robert Risinger, New Haven, CT (US)
Assigned to BioXcel Therapeutics, Inc., New Haven, CT (US)
Filed by BioXcel Therapeutics, Inc., New Haven, CT (US)
Filed on Mar. 8, 2024, as Appl. No. 18/600,419.
Application 18/600,419 is a continuation of application No. 18/526,686, filed on Dec. 1, 2023, granted, now 12,090,140.
Application 18/526,686 is a continuation of application No. 18/189,073, filed on Mar. 23, 2023, granted, now 11,998,528.
Application 18/189,073 is a continuation of application No. 18/153,870, filed on Jan. 12, 2023, granted, now 11,806,334, issued on Nov. 7, 2023.
Prior Publication US 2024/0277669 A1, Aug. 22, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A01N 37/00 (2006.01); A01N 25/00 (2006.01); A01N 37/12 (2006.01); A01N 37/44 (2006.01); A61K 9/00 (2006.01); A61K 31/215 (2006.01); A61K 31/24 (2006.01); A61K 31/4174 (2006.01); A61K 47/38 (2006.01); A61P 25/18 (2006.01); A61P 25/20 (2006.01)
CPC A61K 31/4174 (2013.01) [A61K 9/006 (2013.01); A61K 47/38 (2013.01); A61P 25/18 (2018.01); A61P 25/20 (2018.01)] 18 Claims
 
1. A method of treating acute agitation 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 and;
wherein the agitated human subject exhibits a maximum allowed QT prolongation of less than 7 msec.