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intra-nasal fentanyl
Intra-nasal fentanyl is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to rapidly produce analgesia and sedation.
Intra-nasal fentanyl is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to rapidly produce analgesia and sedation. Used for Breakthrough pain in opioid-tolerant patients with cancer, Acute pain management.
At a glance
| Generic name | intra-nasal fentanyl |
|---|---|
| Sponsor | Genesys |
| Drug class | Opioid agonist |
| Target | Mu-opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Fentanyl is a synthetic opioid that crosses the blood-brain barrier and activates mu-opioid receptors, which modulate pain perception and emotional responses to pain. The intranasal formulation allows rapid absorption through the nasal mucosa, providing faster onset compared to oral administration, making it suitable for acute pain management and breakthrough pain in opioid-tolerant patients.
Approved indications
- Breakthrough pain in opioid-tolerant patients with cancer
- Acute pain management
Common side effects
- Respiratory depression
- Dizziness
- Nausea
- Somnolence
- Headache
- Constipation
Key clinical trials
- Pain Managment in Preterm Neonates (PHASE2, PHASE3)
- Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting (PHASE4)
- Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults. (PHASE3)
- A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain (PHASE1, PHASE2)
- Intranasal Fentanyl for Pain Management (PHASE4)
- Dexmedetomidine vs Fentanyl for BMT (PHASE4)
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:
- intra-nasal fentanyl CI brief — competitive landscape report
- intra-nasal fentanyl updates RSS · CI watch RSS
- Genesys portfolio CI