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Nasal fentanyl
Nasal fentanyl is a Opioid agonist Small molecule drug developed by Nycomed. It is currently in Phase 3 development for Acute pain management, Breakthrough pain in opioid-tolerant patients. Also known as: Instanyl.
Nasal fentanyl is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to provide rapid pain relief through intranasal delivery.
Nasal fentanyl is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to provide rapid pain relief through intranasal delivery. Used for Acute pain management, Breakthrough pain in opioid-tolerant patients.
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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 | Nasal fentanyl |
|---|---|
| Also known as | Instanyl |
| Sponsor | Nycomed |
| Drug class | Opioid agonist |
| Target | Mu-opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Fentanyl is a synthetic opioid that activates mu-opioid receptors, inhibiting pain signal transmission and producing analgesia. The nasal formulation allows for rapid absorption through the nasal mucosa, bypassing first-pass hepatic metabolism and providing faster onset compared to oral routes. This makes it particularly suitable for acute or breakthrough pain management.
Approved indications
- Acute pain management
- Breakthrough pain in opioid-tolerant patients
Common side effects
- Drowsiness/sedation
- Dizziness
- Nausea
- Respiratory depression
- Nasal irritation
Key clinical trials
- 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
- THRIVE in Sedated Gastrointestinal Endoscopy
- General Anesthesia vs Conscious Sedation for Radial Endobronchial Ultrasound (NA)
- Supraglottic Jet Oxygenation Ventilation During Hysteroscopic Surgery (NA)
- General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients (NA)
- Opioid-Free vs Opioid-Based Anesthesia for Nasal Surgeries (PHASE3)
- Comparison of the Effects of Target-Controlled Infusion Method and Manual Propofol Administration on Respiratory Function, Recovery, and Electroencephalogram in Endoscopic Submucosal Dissection Cases (NA)
- Blocking Sphenopalatine Ganglion by Intranasal Lidocaine Spray in Partial Turbinectomy Surgeries (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:
- Nasal fentanyl CI brief — competitive landscape report
- Nasal fentanyl updates RSS · CI watch RSS
- Nycomed portfolio CI
Frequently asked questions about Nasal fentanyl
What is Nasal fentanyl?
How does Nasal fentanyl work?
What is Nasal fentanyl used for?
Who makes Nasal fentanyl?
Is Nasal fentanyl also known as anything else?
What drug class is Nasal fentanyl in?
What development phase is Nasal fentanyl in?
What are the side effects of Nasal fentanyl?
What does Nasal fentanyl target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu-opioid receptor (OPRM1)
- Manufacturer: Nycomed — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Acute pain management
- Indication: Drugs for Breakthrough pain in opioid-tolerant patients
- Also known as: Instanyl
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing