IP Library Granted Patent US 11,786,508
Granted Patent B2
US 11,786,508 · App. 17/990,312 · Granted Oct 17, 2023

Use of sublingual dexmedetomidine for the treatment of agitation

Inventors: Krishnan Nandabalan (New Haven, CT); Frank Yocca (New Haven, CT); Sameer Sharma (New Haven, CT); Harsh Negi (New Delhi, IN); Deepa Saini (Ghaziabad, IN)
Assignee: BioXcel Therapeutics, Inc.
A61K31/4174A61K9/006A61K9/2027A61K45/06A61K47/10
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Quick Facts
Patent No.
US 11,786,508
App. No.
17/990,312
Granted
Oct 17, 2023
Kind
B2
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.

Claims (6)

1. A method of treating agitation in an agitated subject, said agitated subject having schizophrenia, 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; and wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered in a solid, water-soluble dosage form and wherein the dosage form is a film.

2. The method of claim 1 , wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered sublingually.

3. The method of claim 1 , wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is administered buccally.

4. The method of claim 1 , wherein said dexmedetomidine or a pharmaceutically acceptable salt thereof is dexmedetomidine hydrochloride.

5. The method of claim 1 , wherein the agitation is acute agitation.

6. The method of claim 1 , wherein the agitation is chronic agitation.

Assignments (8)
SECURITY INTEREST Recorded Sep 11, 2024
From: BIOXCEL THERAPEUTICS, INC.
To: OAKTREE FUND ADMINISTRATION, LLC
Reel/Frame 068938/0906 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2023
From: BIOXCEL CORPORATION
To: BIOXCEL THERAPEUTICS, INC.
Reel/Frame 062952/0147 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2023
From: YOCCA, FRANK
To: BIOXCEL THERAPEUTICS, INC.
Reel/Frame 062952/0170 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2023
From: SHARMA, SAMEER
To: E. Z. BIOXCEL SOLUTIONS PVT. LTD.
Reel/Frame 062952/0198 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2023
From: NANDABALAN, KRISHNAN
To: BIOXCEL CORPORATION
Reel/Frame 062952/0101 →
INVENTION ASSIGNMENT AGREEMENT (EMPLOYMENT) Recorded Mar 10, 2023
From: SAINI, DEEPA
To: E. Z. BIOXCEL SOLUTIONS PVT. LTD.
Reel/Frame 064020/0270 →
INVENTION ASSIGNMENT AGREEMENT (EMPLOYMENT) Recorded Mar 10, 2023
From: NEGI, HARSH
To: E. Z. BIOXCEL SOLUTIONS PVT. LTD.
Reel/Frame 064020/0590 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2023
From: E. Z. BIOXCEL SOLUTIONS PVT. LTD.
To: BIOXCEL THERAPEUTICS, INC.
Reel/Frame 062952/0205 →
Continuity (5)
Continuation 16474882
Provisional Application 62542323 · Aug 8, 2017
Provisional Application 62471393 · Mar 15, 2017
Provisional Application 62441164 · Dec 31, 2016
Related Publication 20230081503A1 · Mar 16, 2023