Last reviewed · How we verify
Fentanyl Buccal Tablet (FBT)
Fentanyl Buccal Tablet (FBT) is a potent opioid analgesic developed by Cephalon for the management of breakthrough pain in cancer patients who are already receiving and tolerant to opioid therapy. The drug is administered buccally, allowing for rapid absorption and onset of action. Despite its efficacy, FBT carries significant risks, including respiratory depression and misuse potential, which are highlighted in its safety profile. The drug has no FDA-approved label, indicating that it may be used under specific conditions or off-label. Commercially, FBT faces competition from other opioid analgesics and is subject to strict regulatory oversight due to its high potency and potential for abuse.
At a glance
| Generic name | Fentanyl Buccal Tablet (FBT) |
|---|---|
| Also known as | Fentora, CEP-25608, Fentanyl citrate, Effentora |
| Sponsor | Cephalon |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor (MOR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- Risk of life-threatening respiratory depression
- Accidental exposure to FBT can cause fatal overdose
- Risks associated with misuse and abuse
Common side effects
Drug interactions
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
- CYP3A4 inducers (e.g., rifampin, carbamazepine)
- Central nervous system (CNS) depressants (e.g., benzodiazepines, alcohol)
Key clinical trials
- Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients (PHASE3)
- Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea (PHASE2)
- Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury (PHASE3)
- 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)
- Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain (PHASE3)
- Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US7045145B2 | ||
| US7220447B2 |
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 |
| FDA Orange Book | Patents + exclusivity |
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 (FBT) CI brief — competitive landscape report
- Fentanyl Buccal Tablet (FBT) updates RSS · CI watch RSS
- Cephalon portfolio CI