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Buprenorphine Naloxone
Buprenorphine acts as a partial mu-opioid agonist while naloxone acts as a mu-opioid antagonist, together reducing opioid cravings and withdrawal symptoms while deterring misuse.
Buprenorphine acts as a partial mu-opioid agonist while naloxone acts as a mu-opioid antagonist, together reducing opioid cravings and withdrawal symptoms while deterring misuse. Used for Opioid use disorder maintenance treatment, Opioid dependence.
At a glance
| Generic name | Buprenorphine Naloxone |
|---|---|
| Also known as | Suboxone |
| Sponsor | Johns Hopkins University |
| Drug class | Opioid agonist-antagonist combination |
| Target | Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | FDA-approved |
Mechanism of action
Buprenorphine binds with high affinity to mu-opioid receptors as a partial agonist, providing sufficient opioid activity to prevent withdrawal and reduce cravings while having a ceiling effect that limits euphoria and overdose risk. Naloxone is included as a mu-opioid antagonist that becomes active if the combination is injected intravenously, discouraging intravenous misuse. Together, this combination is used for opioid use disorder maintenance treatment.
Approved indications
- Opioid use disorder maintenance treatment
- Opioid dependence
Common side effects
- Headache
- Constipation
- Nausea
- Insomnia
- Sweating
- Withdrawal symptoms (if inadequately dosed)
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (PHASE2)
- A Bundled Intervention - Phase 2 (PHASE4)
- INDV-6001 Multiple-Dose Pharmacokinetic Study (PHASE2)
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
- EMS-Initiated Buprenorphine
- Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (PHASE4)
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:
- Buprenorphine Naloxone CI brief — competitive landscape report
- Buprenorphine Naloxone updates RSS · CI watch RSS
- Johns Hopkins University portfolio CI