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oxycodone naloxone tablet
oxycodone naloxone tablet is a Opioid analgesic with abuse-deterrent formulation Small molecule drug developed by Mundipharma Research GmbH & Co KG. It is currently FDA-approved for Moderate to severe chronic pain in opioid-tolerant patients, Abuse-deterrent formulation for reduced misuse risk. Also known as: Targin®.
Oxycodone acts as a mu-opioid receptor agonist to provide analgesia, while naloxone is an opioid antagonist included to reduce abuse potential by blocking euphoric effects if the tablet is tampered with.
Oxycodone naloxone tablets are used to treat opioid-use disorder, chronic pain, withdrawal symptoms, low back pain, and severe chronic pain. They are a small molecule medication that works by binding to opioid receptors in the body.
At a glance
| Generic name | oxycodone naloxone tablet |
|---|---|
| Also known as | Targin® |
| Sponsor | Mundipharma Research GmbH & Co KG |
| Drug class | Opioid analgesic with abuse-deterrent formulation |
| Target | Mu-opioid receptor (oxycodone); opioid receptors (naloxone antagonism) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Oxycodone binds to mu-opioid receptors in the central nervous system to produce pain relief and is a Schedule II controlled substance. Naloxone is a competitive opioid antagonist added in a fixed ratio; when the tablet is taken intact orally, naloxone is poorly absorbed and has minimal effect, but if the tablet is crushed or dissolved for injection or inhalation, naloxone becomes bioavailable and blocks opioid effects, thereby deterring abuse.
Approved indications
- Moderate to severe chronic pain in opioid-tolerant patients
- Abuse-deterrent formulation for reduced misuse risk
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Vomiting
- Headache
Key clinical trials
- Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain (PHASE4)
- Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) (PHASE1)
- Evaluation of Oral PF614 Relative to OxyContin (PF614-102) (PHASE1)
- Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (PHASE2, PHASE3)
- Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section (PHASE4)
- Efficacy of Computer Delivered Community Reinforcement Approach (CRA) (Bup II) (NA)
- Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology (PHASE4)
- Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- oxycodone naloxone tablet CI brief — competitive landscape report
- oxycodone naloxone tablet updates RSS · CI watch RSS
- Mundipharma Research GmbH & Co KG portfolio CI
Frequently asked questions about oxycodone naloxone tablet
What is oxycodone naloxone tablet?
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Related
- Drug class: All Opioid analgesic with abuse-deterrent formulation drugs
- Target: All drugs targeting Mu-opioid receptor (oxycodone); opioid receptors (naloxone antagonism)
- Manufacturer: Mundipharma Research GmbH & Co KG — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to severe chronic pain in opioid-tolerant patients
- Indication: Drugs for Abuse-deterrent formulation for reduced misuse risk
- Also known as: Targin®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing