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Transmucosal Buprenorphine
Transmucosal Buprenorphine is a Partial mu-opioid receptor agonist Small molecule drug developed by Indivior Inc.. It is currently FDA-approved for Opioid use disorder maintenance treatment, Acute pain management, Chronic pain.
Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to reduce opioid cravings and withdrawal symptoms while producing a ceiling effect on respiratory depression.
Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to reduce opioid cravings and withdrawal symptoms while producing a ceiling effect on respiratory depression. Used for Opioid use disorder maintenance treatment, Acute pain management, Chronic pain.
At a glance
| Generic name | Transmucosal Buprenorphine |
|---|---|
| Sponsor | Indivior Inc. |
| Drug class | Partial mu-opioid receptor agonist |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Buprenorphine acts as a partial agonist at the mu-opioid receptor, meaning it produces submaximal effects compared to full agonists like morphine. This partial agonism provides analgesia and reduces withdrawal symptoms in opioid-dependent patients while having a built-in safety ceiling that limits respiratory depression risk. The transmucosal formulation allows absorption through oral mucosa, providing rapid onset suitable for maintenance treatment and acute pain management.
Approved indications
- Opioid use disorder maintenance treatment
- Acute pain management
- Chronic pain
Common side effects
- Headache
- Nausea
- Constipation
- Dizziness
- Sweating
- Insomnia
- Respiratory depression
Key clinical trials
- A Study of Brenipatide in Participants With Opioid Use Disorder (PHASE2)
- Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users (PHASE4)
- Collaborating to Heal Addiction and Mental Health in Primary Care (NA)
- Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults (PHASE4)
- SUBLOCADE Rapid Initiation Study (PHASE4)
- An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (PHASE2)
- Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
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:
- Transmucosal Buprenorphine CI brief — competitive landscape report
- Transmucosal Buprenorphine updates RSS · CI watch RSS
- Indivior Inc. portfolio CI
Frequently asked questions about Transmucosal Buprenorphine
What is Transmucosal Buprenorphine?
How does Transmucosal Buprenorphine work?
What is Transmucosal Buprenorphine used for?
Who makes Transmucosal Buprenorphine?
What drug class is Transmucosal Buprenorphine in?
What development phase is Transmucosal Buprenorphine in?
What are the side effects of Transmucosal Buprenorphine?
What does Transmucosal Buprenorphine target?
Related
- Drug class: All Partial mu-opioid receptor agonist drugs
- Target: All drugs targeting Mu-opioid receptor (μ-OR)
- Manufacturer: Indivior Inc. — full pipeline
- Therapeutic area: All drugs in Pain Management, Addiction Medicine
- Indication: Drugs for Opioid use disorder maintenance treatment
- Indication: Drugs for Acute pain management
- Indication: Drugs for Chronic pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing