US 11,806,334 B1
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 Jan. 12, 2023, as Appl. No. 18/153,870.
Int. Cl. A01N 37/00 (2006.01); A61K 31/215 (2006.01); A01N 37/12 (2006.01); A01N 37/44 (2006.01); A61K 31/24 (2006.01); A01N 25/00 (2006.01); A61K 31/4174 (2006.01); A61K 9/00 (2006.01); A61P 25/20 (2006.01); A61P 25/18 (2006.01); A61K 47/38 (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)] 5 Claims
 
1. A method of treating agitation associated with schizophrenia or bipolar I or II disorder in a human subject comprising:
administering an initial dose of dexmedetomidine or a pharmaceutically acceptable salt thereof in an oromucosal formulation to the human;
administering a second dose of dexmedetomidine or the pharmaceutically acceptable salt thereof in the oromucosal formulation to the human subject at least two hours after and within 24 hours of the initial dose; and
administering a third dose of dexmedetomidine or the pharmaceutically acceptable salt thereof in the oromucosal formulation to the human subject at least two hours after the second dose and within 24 hours of the initial dose;
wherein the administration of the dexmedetomidine does not exceed a maximum total daily dosage;
wherein the human subject has a severe hepatic impairment and the agitation is severe;
and
wherein the initial dose is 90 mcg of dexmedetomidine, the second and third doses are each 60 mcg of dexmedetomidine, and the maximum total daily dosage is 210 mcg of dexmedetomidine.