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Gaboxadol for reducing risk of suicide and rapid relief of depression

A gaboxadol, risk-based technology, applied in the field of gaboxadol for suicide risk reduction and rapid relief of depression, can solve problems such as failure every three days or more

Pending Publication Date: 2021-09-14
CERTEGO THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] None of the above techniques address acute treatment of patients with acute suicidal tendencies and treatment-resistant depression by administering high doses (eg, >50 mg per dose) of gaboxadol once or intermittently every three days or longer

Method used

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  • Gaboxadol for reducing risk of suicide and rapid relief of depression
  • Gaboxadol for reducing risk of suicide and rapid relief of depression
  • Gaboxadol for reducing risk of suicide and rapid relief of depression

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0198] Example 1: Whole Brain Drug Screening Platform

[0199] Numerous preclinical trials are currently being used to attempt to elucidate or predict the clinical effects of new drugs on the brain. These include in vitro high content screening (HCS) assays that measure the pharmacokinetics of drugs against specific molecular targets and their effects in simple cellular assays, at relatively low resolution (PET / CT, PET / MRI, fMRI) or Local responses at high cellular resolution (electrophysiological or two-photon imaging) to measure in vivo analysis of global responses, as well as to measure the behavior of animals performing in various tasks (Jain and Heutink, 2010; Judenhofer et al., 2008; Markou et al., 2009) analyze. Despite considerable effort in preclinical research, the clinical effects of drugs remain unpredictable, plaguing the drug development pipeline, resulting in clinical trial failure rates exceeding 90% (Pammolli et al., 2011).

[0200]The unique and novel appro...

Embodiment 2

[0202] Example 2: Mapping of brain activation based on the effect of ketamine as a fast-acting antidepressant

[0203] Conventional antidepressants, when administered acutely in single doses, are chosen to match human equivalent doses used in clinical depression treatment to elicit discreet patterns of brain activation including frontal cortex, stria terminalis, bed nucleus ( BST), central amygdala (CEA), paraventricular hypothalamus (PVH), paraventricular thalamic nucleus (PVT) and locus coeruleus (LC) (Slattery et al, 2005; Sumner et al, 2004). Recently, intravenous ketamine, administered acutely at sub-anaesthetic doses, has been shown to act as a very rapid and robust antidepressant, producing a positive therapeutic effect within a few hours, rather than the typical two-fold required for the therapeutic effect of traditional antidepressants. to three weeks. While this exciting and novel clinical benefit of ketamine has been reproduced in numerous clinical studies, the mec...

Embodiment 3

[0206] Example 3: Discovery of unexpected potential for gaboxadol to have rapid antidepressant and antisuicidal effects

[0207] Ketamine doses of 10 mg / kg elicited extensive activation in pharmacodynamic assays and were also shown to have acute effects in many behavioral studies in mice used to model depression, such as forced swimming, tail suspension, and learned helplessness. positive effects. Importantly, the corresponding HED of 50 mg ketamine per 60 kg male is in the human dose range of 0.5 to 1 mg / kg, which is used to achieve rapid antidepressant effects and reduce clinical depression even in treatment-resistant patients Suicidal ideation in patients. Therefore, our pharmacodynamic-based prediction is that the above-described 10 mg / kg ketamine-induced activation pattern represents a neuronal circuit-based mechanism of action for the rapid and significant therapeutic effects of ketamine in depression and suicidal ideation seen in the clinic. Based on this hypothesis, ...

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Abstract

Methods and compositions are disclosed for rapidly reducing the risk of suicide in patients suffering from acute suieidality and rapidly relieving mood symptoms in major depression and treatment-resistant depression using a novel therapeutic regimen comprising a single or intermittent administration of a high dose of gaboxadol, or a pharmaceutically acceptable salt thereof, to the subject in need thereof.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims priority to Provisional Patent Application No. 62 / 770,287, filed on November 21, 2018, the contents of which are incorporated herein by reference in their entirety. technical field [0003] The present invention relates to rapidly reducing the risk of suicide in patients with acute suicidal tendencies using a novel treatment regimen comprising single or intermittent administration of high doses of gaboxadol or a pharmaceutically acceptable salt thereof to a subject in need thereof and Methods and compositions for rapid relief of mood symptoms of major depressive disorder and treatment-resistant depression. Background technique [0004] According to the World Health Organization, depression is the world's leading cause of disability and ill health, affecting more than 300 million people worldwide and costing the global economy an estimated $1 trillion in lost productivity each year. The Centers ...

Claims

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Application Information

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IPC IPC(8): A61K31/437A61P25/24C07D413/00A61K31/33A61K31/42A61B5/374
CPCA61P25/24A61K31/135A61K31/437A61P25/00A61K2300/00A61K45/06
Inventor 帕维尔·奥斯滕克里斯廷·鲍德温
Owner CERTEGO THERAPEUTICS
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