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BEMA™
BEMA is a buccal film delivery system that rapidly dissolves in the mouth to deliver active pharmaceutical ingredients through the oral mucosa for faster systemic absorption.
BEMA is a buccal film delivery system that rapidly dissolves in the mouth to deliver active pharmaceutical ingredients through the oral mucosa for faster systemic absorption. Used for Opioid-induced breakthrough pain (primary development indication), Acute pain management.
At a glance
| Generic name | BEMA™ |
|---|---|
| Also known as | Onsolis (fentanyl buccal soluble film) |
| Sponsor | BioDelivery Sciences International |
| Drug class | Buccal film delivery system |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Multiple therapeutic areas |
| Phase | Phase 3 |
Mechanism of action
BEMA (BioErodible MucoAdhesive) is a proprietary drug delivery technology platform consisting of a thin, flexible film that adheres to the buccal mucosa (inside of the cheek) and rapidly dissolves to deliver medication. This route bypasses first-pass hepatic metabolism and provides faster onset compared to oral tablets, while avoiding injection. The technology has been applied to various active ingredients including opioids and other therapeutics.
Approved indications
- Opioid-induced breakthrough pain (primary development indication)
- Acute pain management
Common side effects
- Oral irritation or mucosal irritation
- Nausea
- Dizziness
- Headache
Key clinical trials
- Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects (PHASE3)
- Long-term Extension Study of BEMA™ Fentanyl (PHASE3)
- Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy (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 |