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Buprenorphine, Naloxone Drug Combination

Buprenorphine, Naloxone Drug Combination is a Opioid agonist-antagonist combination Small molecule drug developed by The University of Texas Health Science Center, Houston. It is currently FDA-approved for Opioid use disorder maintenance treatment, Opioid dependence. Also known as: Suboxone.

Buprenorphine acts as a partial mu-opioid receptor agonist while naloxone acts as a mu-opioid receptor antagonist, together reducing opioid cravings and withdrawal symptoms while deterring misuse.

Buprenorphine acts as a partial mu-opioid receptor agonist while naloxone acts as a mu-opioid receptor antagonist, together reducing opioid cravings and withdrawal symptoms while deterring misuse. Used for Opioid use disorder maintenance treatment, Opioid dependence.

At a glance

Mechanism of action

Buprenorphine's partial agonist activity at the mu-opioid receptor provides sufficient opioid effect to prevent withdrawal and reduce cravings, while its high receptor binding affinity blocks the euphoric effects of additional opioids. Naloxone, included in the combination, is a competitive opioid antagonist that becomes active if the combination is injected intravenously, discouraging intravenous abuse. Together, this combination provides safer opioid maintenance therapy with lower overdose risk compared to full mu-opioid agonists.

Approved indications

• Opioid use disorder maintenance treatment
• Opioid dependence

Common side effects

• Headache
• Constipation
• Nausea
• Sweating
• Insomnia
• 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
• Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (PHASE4)
• Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Buprenorphine, Naloxone Drug Combination CI brief — competitive landscape report
• Buprenorphine, Naloxone Drug Combination updates RSS · CI watch RSS
• The University of Texas Health Science Center, Houston portfolio CI

Frequently asked questions about Buprenorphine, Naloxone Drug Combination

Related

• Drug class: All Opioid agonist-antagonist combination drugs
• Target: All drugs targeting Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist)
• Manufacturer: The University of Texas Health Science Center, Houston — full pipeline
• Therapeutic area: All drugs in Addiction Medicine / Substance Use Disorder
• Indication: Drugs for Opioid use disorder maintenance treatment
• Indication: Drugs for Opioid dependence
• Also known as: Suboxone
• Compare: Buprenorphine, Naloxone Drug Combination vs similar drugs
• Pricing: Buprenorphine, Naloxone Drug Combination cost, discount & access