GC-C Agonist Peptides for Opioid-Induced Bowel Dysfunction

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Solution Overview

Problem

Opioids used for pain management often cause debilitating adverse effects such as opioid-induced bowel dysfunction, respiratory depression, and esophageal dysfunction, for which effective treatments are lacking.

Innovation Solution

The use of guanylate cyclase C (GC-C) agonists, specifically peptides with defined amino acid sequences, to prevent or alleviate opioid-induced dysfunctions by enhancing fluid secretion and gastrointestinal motility, potentially combined with opioids and cGMP-dependent phosphodiesterase inhibitors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If opioids are administered for pain management, then pain relief is achieved, but opioid-induced bowel dysfunction and other adverse effects occur

Engineering Contradiction:
Improvepain relief efficacyVSAvoidopioid-induced bowel dysfunction
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The patent introduces GC-C agonists as intermediary substances that mediate between the harmful effects of opioids and the desired pain relief. The GC-C agonist acts as a separate therapeutic agent that counteracts opioid-induced bowel dysfunction through a different mechanism (guanylate cyclase activation) without interfering with opioid analgesic effects, thus resolving the contradiction by adding a mediator rather than modifying the opioid itself

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the therapeutic parameter by introducing a second agent (GC-C agonist) with different pharmacological properties. Instead of trying to modify opioid parameters to reduce side effects, the solution changes to a combination therapy where the GC-C agonist operates through a separate pathway (increasing cGMP, stimulating chloride secretion) to counteract bowel dysfunction while allowing opioid pain relief to continue

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If conventional laxatives are used to treat opioid-induced constipation, then bowel movement is stimulated, but they are ineffective for severe cases

Engineering Contradiction:
Improvetreatment accessibilityVSAvoidtreatment effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the pharmacological parameter from conventional laxative mechanisms to GC-C agonist mechanism. The GC-C agonist works by activating guanylate cyclase C receptors, increasing intracellular cGMP, and stimulating chloride secretion through CFTR channels - a fundamentally different parameter pathway than conventional laxatives, which explains its superior effectiveness in severe cases while maintaining ease of administration

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent segments the treatment approach by separating the pain management function (opioid) from the bowel dysfunction treatment function (GC-C agonist). This segmentation allows each agent to optimize its specific function without the limitations of conventional combined approaches, where the GC-C agonist specifically targets the bowel dysfunction pathway independent of opioid dosage

Inventive Principle:
Principle #1Segmentation

3Reliability

If GC-C agonists are combined with opioids, then bowel dysfunction is alleviated, but drug interaction complexity increases

Engineering Contradiction:
Improvetreatment efficacyVSAvoidcombination therapy complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The GC-C agonist serves as an intermediary therapeutic agent that bridges the gap between opioid administration and bowel function restoration. By acting through a completely different receptor system (GC-C rather than opioid receptors), it mediates bowel dysfunction relief without complex pharmacokinetic interactions, simplifying the combination therapy compared to agents that might compete for the same metabolic pathways

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts the bowel dysfunction treatment function from the opioid therapy itself, creating a separate, independent therapeutic pathway. The GC-C agonist is extracted as a distinct agent with its own mechanism of action, allowing it to be added to the regimen without complicating the opioid's primary pain relief function, thus managing complexity by separation rather than integration

Inventive Principle:
Principle #2Taking out (Extraction)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The GC-C agonists effectively alleviate opioid-induced bowel dysfunction by stimulating chloride currents and activating PKG-II, leading to improved gastrointestinal transit and fecal output, while also being compatible with opioid administration.

Implementation Method 1

guanylate cyclase C (GC-C) agonists, specifically peptides with defined amino acid sequences, to prevent or alleviate opioid-induced dysfunctions by enhancing fluid secretion and gastrointestinal motility

Methodology Applied
Scientific EffectGuanylate cyclase activation:

Implementation Method 2

The GC-C agonists effectively alleviate opioid-induced bowel dysfunction by stimulating chloride currents and activating PKG-II

Methodology Applied
Scientific EffectChloride current stimulation:

Implementation Method 3

The composition may further comprise an opioid and/or a cGMP-dependent phosphodiesterase inhibitor

Methodology Applied
Scientific EffectcGMP signaling:

Data Source

PatentEP3054969B1Agonists of guanylate cyclase useful for the treatment of opioid induced dysfunctions
Publication Date: 2021.03.10 BAUSCH HEALTH IRELAND LTD
  • EP3054969B1 patent drawingFigure 1
  • EP3054969B1 patent drawingFigure 2
  • EP3054969B1 patent drawingFigure 3A~3B

AI summary

This invention provides a method to prevent, control, and/or treat opioid induced dysfunctions comprising administering to a patient in need a guanylate cyclase receptor agonist (GCRA) peptide. Compositions comprising guanylate cyclase receptor agonist (GCRA) peptides, methods of making, and methods of treatment are also disclosed.