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DFN-15 Active
DFN-15 is a buprenorphine sublingual tablet formulation designed to provide rapid onset and consistent opioid receptor agonism for pain management.
DFN-15 is a buprenorphine sublingual tablet formulation designed to provide rapid onset and consistent opioid receptor agonism for pain management. Used for Moderate to severe acute pain.
At a glance
| Generic name | DFN-15 Active |
|---|---|
| Also known as | Celecoxib Oral Solution |
| Sponsor | BioDelivery Sciences International |
| Drug class | Partial mu-opioid receptor agonist |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
DFN-15 contains buprenorphine, a partial mu-opioid receptor agonist, formulated as a sublingual tablet to enable faster absorption and more predictable pharmacokinetics compared to traditional buprenorphine formulations. The partial agonist activity at the mu-opioid receptor provides analgesia while maintaining a lower abuse potential and ceiling effect on respiratory depression compared to full opioid agonists.
Approved indications
- Moderate to severe acute pain
Common side effects
- Nausea
- Dizziness
- Headache
- Constipation
- Somnolence
Key clinical trials
- Efficacy, Tolerability, and Safety of DFN-15 (PHASE3)
- Efficacy, Tolerability, and Safety Study of DFN-15 (PHASE3)
- Can DFN-15 Terminate Migraine With Allodynia? (PHASE2)
- Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches (PHASE2)
- Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults (PHASE1)
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:
- DFN-15 Active CI brief — competitive landscape report
- DFN-15 Active updates RSS · CI watch RSS
- BioDelivery Sciences International portfolio CI