Amisulpride D2/5HT2 Antagonism for PONV Prevention

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Solution Overview

Problem

Postoperative nausea and vomiting (PONV) remains a significant issue in surgical patients, affecting approximately 30% of all surgical patients and 70% of high-risk patients, despite routine use of prophylactic anti-emetics, with existing agents showing limited efficacy and potential for adverse effects, particularly in high-risk groups.

Innovation Solution

Amisulpride, a dopamine D2/serotonin 5HT2 antagonist, is administered as a single chiral enantiomer or racemate, particularly effective in high-risk patients with multiple risk factors for PONV, such as history of nausea, non-smoking status, and female gender, offering a higher relative risk reduction in postoperative emesis incidence when used in combination with other anti-emetic agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If routine prophylactic anti-emetics are used in moderate and high-risk patients, then PONV prevention is provided, but PONV still occurs in about 30% of cases

Engineering Contradiction:
ImprovePONV prevention efficacyVSAvoidresidual PONV incidence
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces amisulpride, a dopamine D2/serotonin 5HT2 antagonist with a different mechanism of action compared to existing 5HT3 antagonists and NK1 antagonists. This represents a parameter change in the pharmacological approach by targeting different receptor systems (dopaminergic and serotoninergic pathways) to achieve enhanced anti-emetic efficacy where conventional agents have failed

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent promotes combination therapy using amisulpride together with other anti-emetic agents from different classes (5HT3 antagonists like ondansetron, granisetron, palonosetron; NK1 antagonists like aprepitant, netupitant, rolapitant; or dexamethasone). This composite approach combines multiple mechanisms of action to provide synergistic protection against PONV, reducing the 30% residual incidence through multi-target coverage

Inventive Principle:
Principle #40Composite materials

2Adaptability or versatility

If existing anti-emetic agents are used, then some PONV protection is achieved, but there remains a significant need for additional agents with different mechanisms of action

Engineering Contradiction:
Improveavailability of anti-emetic agents with different mechanismsVSAvoidcompleteness of PONV prevention coverage
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

Amisulpride exhibits multi-functionality by acting on both dopamine D2 and serotonin 5HT2 receptors simultaneously. This dual mechanism provides versatile anti-emetic coverage that complements existing single-mechanism agents, filling the gap for medications with different modes of action while maintaining broad spectrum effectiveness across diverse patient populations and surgical types

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If combination therapy with amisulpride and other anti-emetic agents is used, then relative risk reduction of 31% in emesis occurrence is achieved, but drug interaction complexity increases

Engineering Contradiction:
Improveemesis prevention efficacyVSAvoidcombination therapy regimen complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Amisulpride serves as an intermediary agent that bridges different anti-emetic mechanisms by combining dopaminergic and serotoninergic blockade. When used in combination with 5HT3 antagonists, NK1 antagonists, or dexamethasone, it acts as a complementary mediator that enhances overall efficacy through synergistic interactions, achieving 31% relative risk reduction while the dosing guidelines simplify the management of this multi-component therapy

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Amisulpride significantly reduces the incidence of postoperative emesis, achieving a relative risk reduction of 31% in the occurrence of vomiting and/or retching, with a complete response rate improvement of 20.8% compared to placebo, demonstrating its efficacy in preventing PONV in high-risk surgical patients.

Implementation Method 1

Amisulpride, a dopamine D2/serotonin 5HT2 antagonist

Methodology Applied
Scientific EffectDopamine D2 receptor antagonism:

Implementation Method 2

Amisulpride, a dopamine D2/serotonin 5HT2 antagonist

Methodology Applied
Scientific EffectSerotonin 5HT2 receptor antagonism:

Data Source

PatentEP3534896A1Therapy of post-operative emesis with amisulpride
Publication Date: 2019.09.11 ACACIA PHARMA

AI summary

Amisulpride is useful in the therapy (particularly the prevention) of postoperative emesis in a patient, particularly wherein the patient is undergoing a surgical procedure where postoperative emesis would be potentially dangerous to the patient.