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ORAVESCENT Fentanyl Citrate
ORAVESCENT Fentanyl Citrate is a Opioid agonist Small molecule drug developed by Cephalon. It is currently in Phase 3 development for Breakthrough pain in opioid-tolerant cancer patients.
Fentanyl citrate binds to opioid receptors in the central nervous system to produce analgesia and sedation.
Fentanyl citrate binds to opioid receptors in the central nervous system to produce analgesia and sedation. Used for Breakthrough pain in opioid-tolerant cancer patients.
At a glance
| Generic name | ORAVESCENT Fentanyl Citrate |
|---|---|
| Sponsor | Cephalon |
| Drug class | Opioid agonist |
| Target | Mu (μ) opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Fentanyl is a synthetic opioid agonist that acts primarily on mu (μ) opioid receptors in the brain and spinal cord. ORAVESCENT is a proprietary oral transmucosal formulation designed for rapid absorption through the oral mucosa, allowing faster onset of analgesia compared to conventional oral opioids. This formulation is intended for breakthrough pain management in opioid-tolerant patients.
Approved indications
- Breakthrough pain in opioid-tolerant cancer patients
Common side effects
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Constipation
- Respiratory depression
Key clinical trials
- Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain (PHASE3)
- Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain (PHASE3)
- Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain (PHASE3)
- Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients (PHASE3)
- Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain (PHASE3)
- OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients (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:
- ORAVESCENT Fentanyl Citrate CI brief — competitive landscape report
- ORAVESCENT Fentanyl Citrate updates RSS · CI watch RSS
- Cephalon portfolio CI
Frequently asked questions about ORAVESCENT Fentanyl Citrate
What is ORAVESCENT Fentanyl Citrate?
How does ORAVESCENT Fentanyl Citrate work?
What is ORAVESCENT Fentanyl Citrate used for?
Who makes ORAVESCENT Fentanyl Citrate?
What drug class is ORAVESCENT Fentanyl Citrate in?
What development phase is ORAVESCENT Fentanyl Citrate in?
What are the side effects of ORAVESCENT Fentanyl Citrate?
What does ORAVESCENT Fentanyl Citrate target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu (μ) opioid receptor
- Manufacturer: Cephalon — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Breakthrough pain in opioid-tolerant cancer patients
- Compare: ORAVESCENT Fentanyl Citrate vs similar drugs
- Pricing: ORAVESCENT Fentanyl Citrate cost, discount & access