Last reviewed · How we verify
Oxycodone/Naloxone Prolonged Release tablets
Oxycodone/Naloxone Prolonged Release tablets is a Opioid analgesic with abuse-deterrent formulation Small molecule drug developed by Mundipharma Research GmbH & Co KG. It is currently in Phase 3 development for Chronic moderate to severe pain requiring prolonged opioid therapy.
Oxycodone acts as a mu-opioid receptor agonist to provide analgesia, while naloxone is included to reduce the potential for abuse by blocking opioid effects if the tablet is crushed or dissolved.
Oxycodone acts as a mu-opioid receptor agonist to provide analgesia, while naloxone is included to reduce the potential for abuse by blocking opioid effects if the tablet is crushed or dissolved. Used for Chronic moderate to severe pain requiring prolonged opioid therapy.
-
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 Prolonged Release tablets |
|---|---|
| Sponsor | Mundipharma Research GmbH & Co KG |
| Drug class | Opioid analgesic with abuse-deterrent formulation |
| Target | Mu-opioid receptor (oxycodone); opioid receptors (naloxone antagonism) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Oxycodone binds to mu-opioid receptors in the central nervous system to produce pain relief and is formulated as a prolonged-release tablet for chronic pain management. Naloxone, an opioid antagonist, is incorporated at a low dose that is poorly absorbed orally but becomes active if the formulation is compromised (e.g., crushed for injection), thereby deterring misuse while having minimal impact on the therapeutic opioid effect when taken as intended.
Approved indications
- Chronic moderate to severe pain requiring prolonged opioid therapy
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Vomiting
- Headache
Key clinical trials
- Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section (PHASE4)
- Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain (PHASE3)
- OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients (PHASE1)
- A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain (PHASE2)
- OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS) (PHASE2)
- Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation (PHASE3)
- 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)
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 Prolonged Release tablets CI brief — competitive landscape report
- Oxycodone/Naloxone Prolonged Release tablets updates RSS · CI watch RSS
- Mundipharma Research GmbH & Co KG portfolio CI
Frequently asked questions about Oxycodone/Naloxone Prolonged Release tablets
What is Oxycodone/Naloxone Prolonged Release tablets?
How does Oxycodone/Naloxone Prolonged Release tablets work?
What is Oxycodone/Naloxone Prolonged Release tablets used for?
Who makes Oxycodone/Naloxone Prolonged Release tablets?
What drug class is Oxycodone/Naloxone Prolonged Release tablets in?
What development phase is Oxycodone/Naloxone Prolonged Release tablets in?
What are the side effects of Oxycodone/Naloxone Prolonged Release tablets?
What does Oxycodone/Naloxone Prolonged Release tablets target?
Related
- Drug class: All Opioid analgesic with abuse-deterrent formulation drugs
- Target: All drugs targeting Mu-opioid receptor (oxycodone); opioid receptors (naloxone antagonism)
- Manufacturer: Mundipharma Research GmbH & Co KG — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Chronic moderate to severe pain requiring prolonged opioid therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing