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Oxycodone & naloxone combination, prolonged release
Oxycodone & naloxone combination, prolonged release is a opioid agonist-antagonist Small molecule drug developed by Mundipharma Research GmbH & Co KG. It is currently in Phase 3 development for Moderate to severe pain, Severe pain for patients who are tolerant to other opioids.
Oxycodone is a mu-opioid receptor agonist, while naloxone is a mu-opioid receptor antagonist.
Oxycodone is a mu-opioid receptor agonist, while naloxone is a mu-opioid receptor antagonist. Used for Moderate to severe pain, Severe pain for patients who are tolerant to other opioids.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Oxycodone & naloxone combination, prolonged release |
|---|---|
| Sponsor | Mundipharma Research GmbH & Co KG |
| Drug class | opioid agonist-antagonist |
| Target | mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 3 |
Mechanism of action
Oxycodone works by activating the mu-opioid receptors in the brain, which helps to reduce pain. Naloxone, on the other hand, works by blocking the mu-opioid receptors, which helps to reverse the effects of oxycodone and prevent overdose.
Approved indications
- Moderate to severe pain
- Severe pain for patients who are tolerant to other opioids
Common side effects
- Nausea
- Vomiting
- Constipation
- Dizziness
- Headache
Key clinical trials
- Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section (PHASE4)
- A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain (PHASE3)
- A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy (PHASE3)
- To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain (PHASE2, PHASE3)
- Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery (PHASE4)
- Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients (PHASE3)
- A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain
- Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oxycodone & naloxone combination, prolonged release CI brief — competitive landscape report
- Oxycodone & naloxone combination, prolonged release updates RSS · CI watch RSS
- Mundipharma Research GmbH & Co KG portfolio CI
Frequently asked questions about Oxycodone & naloxone combination, prolonged release
What is Oxycodone & naloxone combination, prolonged release?
How does Oxycodone & naloxone combination, prolonged release work?
What is Oxycodone & naloxone combination, prolonged release used for?
Who makes Oxycodone & naloxone combination, prolonged release?
What drug class is Oxycodone & naloxone combination, prolonged release in?
What development phase is Oxycodone & naloxone combination, prolonged release in?
What are the side effects of Oxycodone & naloxone combination, prolonged release?
What does Oxycodone & naloxone combination, prolonged release target?
Related
- Drug class: All opioid agonist-antagonist drugs
- Target: All drugs targeting mu-opioid receptor
- Manufacturer: Mundipharma Research GmbH & Co KG — full pipeline
- Therapeutic area: All drugs in Pain management
- Indication: Drugs for Moderate to severe pain
- Indication: Drugs for Severe pain for patients who are tolerant to other opioids
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing