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Fentanyl Buccal Tablet
Fentanyl buccal tablet delivers the opioid fentanyl through the buccal mucosa to provide rapid analgesia by binding to mu opioid receptors in the central nervous system.
Fentanyl buccal tablet delivers the opioid fentanyl through the buccal mucosa to provide rapid analgesia by binding to mu opioid receptors in the central nervous system. Used for Breakthrough cancer pain in opioid-tolerant patients.
At a glance
| Generic name | Fentanyl Buccal Tablet |
|---|---|
| Also known as | Fentora, CEP-25608 |
| Sponsor | M.D. Anderson Cancer Center |
| Drug class | Opioid analgesic |
| Target | Mu opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fentanyl is a potent synthetic opioid agonist that binds to mu opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and producing analgesia. The buccal tablet formulation allows for rapid transmucosal absorption, bypassing first-pass hepatic metabolism and achieving faster onset compared to oral administration. This formulation is particularly useful for breakthrough pain management in opioid-tolerant patients.
Approved indications
- Breakthrough cancer pain in opioid-tolerant patients
Common side effects
- Somnolence
- Dizziness
- Nausea
- Constipation
- Respiratory depression
Key clinical trials
- Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients (PHASE3)
- Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer Patients (PHASE2)
- Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea (PHASE2)
- Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients (PHASE2)
- Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury (PHASE3)
- Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
- Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain (PHASE3)
- Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients (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:
- Fentanyl Buccal Tablet CI brief — competitive landscape report
- Fentanyl Buccal Tablet updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI