Non-sedating dexmedetomidine treatment regimens
AssigneeBioXcel Therapeutics, Inc.
InventorsVasukumar Kakumanu, David Christian Hanley, Frank Yocca, Chetan Dalpatbhai Lathia, Lavanya Rajachandran, Robert Risinger
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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.
Claims25
A method of treating agitation associated with schizophrenia or bipolar disorder in an agitated human subject, comprising:
- administering a composition comprising a sole active agent to the oromucosal of the agitated human subject, wherein the active agent consists of dexmedetomidine or a pharmaceutically acceptable salt thereof;
- wherein the human subject has a corrected QT interval using Fridericia's correction method (QTcF) of less than 470 msec;
- and
- wherein the subject is administered a first dose of dexmedetomidine or a pharmaceutically acceptable salt thereof, about 120 micrograms to about 180 micrograms.
Dependencies are inferred from the claim text.