Claims for Patent: 11,839,604

Summary for Patent: 11,839,604

Title:	Use of sublingual dexmedetomidine for the treatment of agitation
Abstract:	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.
Inventor(s):	Krishnan Nandabalan, Frank Yocca, Sameer Sharma, Harsh NEGI, Deepa Saini
Assignee:	EZ Bioxcel Solutions Pvt Ltd , Bioxcel Therapeutics Inc , Bioxcel LLC
Application Number:	US16/474,882
Patent Claims:	1. A method of treating agitation in an agitated subject, said agitated subject having bipolar disorder, consisting of administering to the oral mucosa of said agitated subject one or two single dosage administrations of 60 micrograms of dexmedetomidine or a pharmaceutically acceptable salt thereof without also causing significant sedation after the administration, wherein the dexmedetomidine or the pharmaceutically acceptable salt thereof produces an anti-agitation effect in less than about 60 minutes after administration; wherein the agitation is not perioperative agitation; wherein the dexmedetomidine or pharmaceutically acceptable salt is administered in a solid, water-soluble dosage form, and wherein the dosage form is a film. 2. The method according to claim 1, wherein the agitation is acute agitation. 3. The method according to claim 1, wherein the agitation is chronic agitation. 4. The method according to claim 1, wherein the agitation is severe agitation. 5. The method according to claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is administered sublingually. 6. The method according to claim 5, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride. 7. The method according to claim 1, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is administered buccally. 8. The method according to claim 7, wherein the dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride.