Bioxcel Therapeutics, Inc.

Arx Limited

Frank Yocca

David Christian Hanley

Chetan Dalpatbhai Lathia

Vasukumar Kakumanu

Lavanya Rajachandran

Robert Risinger

Scott David Barnhart

Krishnan Nandabalan

Sameer Sharma

Deepa Saini

Harsh Negi

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.

Non-sedating dexmedetomidine treatment regimens

The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.

Use of sublingual dexmedetomidine for the treatment of agitation

Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.

Film formulations containing dexmedetomidine and methods of producing them

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Clinton, CT, United States of America

Frank Yocca