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Non-sedative dexmedetomidine treatment regimen

A dexmedetomidine and sedation technology, applied in the field of non-sedative dexmedetomidine treatment plan, can solve problems such as unsatisfactory

Pending Publication Date: 2022-04-19
BIOXCEL THERAPEUTICS INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Accordingly, there is a continuing, unmet need for an effective dexmedetomidine product that does not cause significant sedation, and is desirably effective without additionally producing significant side effects

Method used

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  • Non-sedative dexmedetomidine treatment regimen
  • Non-sedative dexmedetomidine treatment regimen
  • Non-sedative dexmedetomidine treatment regimen

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0622] Embodiment 1. A method of treating agitation or symptoms of agitation in a human subject with schizophrenia or bipolar disorder without additionally inducing significant sedation, the method comprising producing as by TO Dexmedetomidine or a pharmaceutically acceptable salt thereof was administered at a dose to a mean total exposure of dexmedetomidine of about 3800 ng*h / L as measured by plasma AUC of T∞.

Embodiment approach 2

[0623] Embodiment 2. A method of treating agitation or symptoms of agitation in a human subject with schizophrenia or bipolar disorder without additionally inducing significant sedation, the method comprising producing as by TO Dexmedetomidine or a pharmaceutically acceptable salt thereof is administered at a dose to a total exposure of dexmedetomidine of about 600 to about 12600 ng*h / L as measured by plasma AUC of T∞.

Embodiment approach 3

[0624] Embodiment 3. A method of treating agitation or symptoms of agitation in a human subject with schizophrenia or bipolar disorder without additionally inducing significant sedation, the method comprising producing as by TO Dexmedetomidine or a pharmaceutically acceptable salt thereof was administered at a dose to a mean total exposure of dexmedetomidine of about 1800 ng*h / L as measured by plasma AUC of T∞.

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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 otherwise inducing significant sedation. The disclosed methods are particularly suitable for treating irritability, particularly when associated with neurodegenerative and / or neuropsychiatric disorders such as schizophrenia, bipolar disorders such as bipolar affective disorders or mania, dementia, depression, or delirium.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Patent Application No. 62 / 876,371, filed July 19, 2019, under 35 U.S.C. 119(e); U.S. Provisional Patent Application No. 62 / 877,056, filed July 22, 2019; U.S. Provisional Patent Application No. 62 / 963,769; U.S. Provisional Patent Application No. 62 / 970,411, February 5, 2020; U.S. Provisional Patent Application No. 62 / 977,554, February 17, 2020; U.S. Provisional Patent Application No. 62 / 977,554, February 11, 2020 Patent Application No. 63 / 037,759; priority benefit of U.S. Provisional Patent Application No. 62 / 943,022, filed December 3, 2019; the disclosures of each of which are hereby incorporated by reference in their entirety. technical field [0003] Disclosed herein are methods of treating a human subject with a condition that can be improved with an alpha-2 adrenoceptor agonist, such as agitation. The method comprises administering dexmedetomidine, or a pharmaceutically accep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4174A61K9/70
CPCA61K31/4174A61K9/006A61K47/38A61K9/2018A61K9/7007A61K47/34A61P25/22A61P25/18A61K9/06A61K9/2013A61K9/7015A61K47/10A61K47/26A61K47/44A61P25/36A61P25/20
Inventor V.卡库马努D.C.汉利F.尤卡C.D.拉蒂亚S.D.巴恩哈特L.拉加钱德兰R.里辛格
Owner BIOXCEL THERAPEUTICS INC
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