Last reviewed 2026-06-03 · How we verify

BEMA Fentanyl

BioDelivery Sciences International · Phase 3 active Small molecule Under review Quality 0/100

BEMA Fentanyl is a Opioid analgesic Small molecule drug developed by BioDelivery Sciences International. It is currently in Phase 3 development for Breakthrough pain in opioid-tolerant cancer patients. Also known as: bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS, bioerodible mucoadhesive system.

BEMA Fentanyl is a fentanyl formulation delivered via a buccal mucoadhesive patch that provides rapid opioid analgesia for breakthrough pain.

BEMA Fentanyl is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist. It is used to treat conditions such as respiratory depression, pain, and cancer, specifically breakthrough cancer pain.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BEMA Fentanyl
Also known as	bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS, bioerodible mucoadhesive system
Sponsor	BioDelivery Sciences International
Drug class	Opioid analgesic
Target	Mu-opioid receptor (μ-OR)
Modality	Small molecule
Therapeutic area	Pain Management
Phase	Phase 3

Mechanism of action

BEMA (BioErodible MucoAdhesive) technology allows fentanyl to be absorbed through the buccal mucosa, bypassing first-pass hepatic metabolism and enabling faster onset compared to oral formulations. Fentanyl acts as a mu-opioid receptor agonist, binding to opioid receptors in the central nervous system to produce analgesia and pain relief.

Approved indications

Breakthrough pain in opioid-tolerant cancer patients

Common side effects

Dizziness
Somnolence
Nausea
Headache
Constipation
Respiratory depression

Key clinical trials

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:

BEMA Fentanyl CI brief — competitive landscape report
BEMA Fentanyl updates RSS · CI watch RSS
BioDelivery Sciences International portfolio CI

Frequently asked questions about BEMA Fentanyl

What is BEMA Fentanyl?

BEMA Fentanyl is a Opioid analgesic drug developed by BioDelivery Sciences International, indicated for Breakthrough pain in opioid-tolerant cancer patients.

How does BEMA Fentanyl work?

BEMA Fentanyl is a fentanyl formulation delivered via a buccal mucoadhesive patch that provides rapid opioid analgesia for breakthrough pain.

What is BEMA Fentanyl used for?

BEMA Fentanyl is indicated for Breakthrough pain in opioid-tolerant cancer patients.

Who makes BEMA Fentanyl?

BEMA Fentanyl is developed by BioDelivery Sciences International (see full BioDelivery Sciences International pipeline at /company/biodelivery-sciences-international).

Is BEMA Fentanyl also known as anything else?

BEMA Fentanyl is also known as bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS, bioerodible mucoadhesive system.

What drug class is BEMA Fentanyl in?

BEMA Fentanyl belongs to the Opioid analgesic class. See all Opioid analgesic drugs at /class/opioid-analgesic.

What development phase is BEMA Fentanyl in?

BEMA Fentanyl is in Phase 3.

What are the side effects of BEMA Fentanyl?

Common side effects of BEMA Fentanyl include Dizziness, Somnolence, Nausea, Headache, Constipation, Respiratory depression.

What does BEMA Fentanyl target?

BEMA Fentanyl targets Mu-opioid receptor (μ-OR) and is a Opioid analgesic.

Drug class: All Opioid analgesic drugs
Target: All drugs targeting Mu-opioid receptor (μ-OR)
Manufacturer: BioDelivery Sciences International — full pipeline
Therapeutic area: All drugs in Pain Management
Indication: Drugs for Breakthrough pain in opioid-tolerant cancer patients
Also known as: bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS, bioerodible mucoadhesive system

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing