Delving into the Latest Updates on Naltrexone/Acetaminophen with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ALLOD-2

Target

COXs x Opioid receptors

Action

inhibitors, antagonists

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), Opioid receptors antagonists(Opioid receptors antagonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Acute migraineAdjustment disorders

Inactive Indication

Low Back PainMigraine Without Aura

Originator Organization

Allodynic Therapeutics LLC

Active Organization

Allodynic Therapeutics LLC

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC20H24ClNO4

InChIKeyRHBRMCOKKKZVRY-ITLPAZOVSA-N

CAS Registry16676-29-2

View All Structures (2)

* This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo. In Stage 2 (dose-finding), they will test three doses of the combination. Before both stages, participants will complete a run-in period, documenting a migraine attack without study medication. They will then treat one migraine attack in each stage.
* 4 visits
* Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.

Start Date31 Jan 2025

Sponsor / Collaborator

Allodynic Therapeutics LLC

NCT03194555

/ CompletedPhase 2

Randomized, Double-Blind, Study to Assess Low-Dose Naltrexone and Acetaminophen Combination in the Prevention of Episodic Migraine in Adults

The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders

Start Date25 Aug 2017

Sponsor / Collaborator

Allodynic Therapeutics LLC

NCT03201393

/ CompletedPhase 2

A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Low-Dose Naltrexone and Acetaminophen Combination vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)

Treatment of chronic low-back pain with low-dose naltrexone and acetaminophen combination: a small, randomized, double-Blind, and placebo-controlled clinical trial with an open-label extension for none-responders

Start Date15 Aug 2017

Sponsor / Collaborator

Allodynic Therapeutics LLC

100 Clinical Results associated with Naltrexone/Acetaminophen

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100 Translational Medicine associated with Naltrexone/Acetaminophen

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100 Patents (Medical) associated with Naltrexone/Acetaminophen

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100 Deals associated with Naltrexone/Acetaminophen

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Without Aura	Phase 3	United States	Allodynic Therapeutics LLC	27 Jun 2017
Acute migraine	Phase 2	United States	Allodynic Therapeutics LLC	31 Jan 2025
Low Back Pain	Phase 2	United States	Allodynic Therapeutics LLC	15 Aug 2017
Adjustment disorders	Phase 1	-	Allodynic Therapeutics LLC	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03194555 (CTgov)	Phase 2	Migraine Disorders \| Migraine Without Aura	12	Low-Dose Naltrexone and Acetaminophen Combination (Low-Dose Naltrexone and Acetaminophen Combination)	isufloofov(xamyxyepoy) = qfnukjnkfx kthmyodezz (clcyqkvofl, 3.2) View more	-	10 Apr 2024
				Placebo (Placebo)	isufloofov(xamyxyepoy) = ngsdoecgmc kthmyodezz (clcyqkvofl, 5.56) View more