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Fentanyl (Matrifen)
Fentanyl (Matrifen) is a Opioid agonist Small molecule drug developed by Nycomed. It is currently in Phase 3 development for Chronic pain management in opioid-tolerant patients, Cancer pain.
Fentanyl is a synthetic opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and sedation.
Fentanyl is a synthetic opioid agonist that binds to mu-opioid receptors in the central nervous system to produce analgesia and sedation. Used for Chronic pain management in opioid-tolerant patients, Cancer pain.
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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 | Fentanyl (Matrifen) |
|---|---|
| Sponsor | Nycomed |
| Drug class | Opioid agonist |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Fentanyl activates mu-opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and modulating pain perception. Matrifen is a transdermal patch formulation designed for sustained delivery of fentanyl, providing prolonged analgesia in chronic pain conditions. The transdermal route allows for continuous systemic exposure with reduced dosing frequency compared to immediate-release formulations.
Approved indications
- Chronic pain management in opioid-tolerant patients
- Cancer pain
Common side effects
- Nausea
- Constipation
- Dizziness
- Somnolence
- Headache
- Vomiting
- Application site reactions
Key clinical trials
- Total Intravenous and Balanced Anesthesia in Diabetic Patients Undergoing Video-Assisted Thoracoscopy (PHASE4)
- The Relationship Between Opioid-Free Anesthesia and Postoperative Agitation-Delirium and Quality of Recovery in Pediatric Ear, Nose, and Throat Cases Monitored With Perioperative Bispectral Index
- EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives (NA)
- Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine (PHASE3)
- A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade (PHASE2)
- Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (PHASE1)
- HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids (NA)
- Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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:
- Fentanyl (Matrifen) CI brief — competitive landscape report
- Fentanyl (Matrifen) updates RSS · CI watch RSS
- Nycomed portfolio CI
Frequently asked questions about Fentanyl (Matrifen)
What is Fentanyl (Matrifen)?
How does Fentanyl (Matrifen) work?
What is Fentanyl (Matrifen) used for?
Who makes Fentanyl (Matrifen)?
What drug class is Fentanyl (Matrifen) in?
What development phase is Fentanyl (Matrifen) in?
What are the side effects of Fentanyl (Matrifen)?
What does Fentanyl (Matrifen) target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Nycomed — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Chronic pain management in opioid-tolerant patients
- Indication: Drugs for Cancer pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing