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EN3409
EN3409 is a buprenorphine formulation designed to provide sustained opioid receptor agonism with reduced abuse potential through a specialized delivery technology.
EN3409 is a buprenorphine formulation designed to provide sustained opioid receptor agonism with reduced abuse potential through a specialized delivery technology. Used for Moderate to severe chronic pain, Opioid use disorder (maintenance treatment).
At a glance
| Generic name | EN3409 |
|---|---|
| Also known as | Buprenorphine HCI Buccal Film 300-900 mcg twice daily |
| Sponsor | BioDelivery Sciences International |
| Drug class | Partial mu-opioid receptor agonist |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Opioid Use Disorder |
| Phase | Phase 3 |
Mechanism of action
EN3409 leverages BioDelivery Sciences' proprietary BEMA (Buccal Mucosa Adhesive) or similar transmucosal delivery technology to deliver buprenorphine, a partial mu-opioid receptor agonist. This approach aims to improve bioavailability, patient compliance, and potentially reduce diversion risk compared to conventional formulations. Buprenorphine's partial agonist activity at the mu-opioid receptor provides analgesia and opioid dependence treatment with a lower overdose risk profile than full agonists.
Approved indications
- Moderate to severe chronic pain
- Opioid use disorder (maintenance treatment)
Common side effects
- Nausea
- Headache
- Dizziness
- Constipation
- Application site irritation
Key clinical trials
- Long-term Open-Label Safety Study to Evaluate EN3409 (PHASE3)
- Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects (PHASE3)
- Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film (PHASE2)
- Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects (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:
- EN3409 CI brief — competitive landscape report
- EN3409 updates RSS · CI watch RSS
- BioDelivery Sciences International portfolio CI