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Oxycodone Naltrexone (b)
Oxycodone naltrexone is a combination of an opioid agonist (oxycodone) and an opioid antagonist (naltrexone) designed to provide analgesia while reducing opioid-related adverse effects and abuse potential.
Oxycodone naltrexone is a combination of an opioid agonist (oxycodone) and an opioid antagonist (naltrexone) designed to provide analgesia while reducing opioid-related adverse effects and abuse potential. Used for Moderate to severe chronic pain.
At a glance
| Generic name | Oxycodone Naltrexone (b) |
|---|---|
| Sponsor | Elite Laboratories, Inc |
| Drug class | Opioid agonist-antagonist combination |
| Target | Mu-opioid receptor (oxycodone); opioid receptors (naltrexone antagonism) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Oxycodone binds to mu-opioid receptors to produce analgesia and pain relief. Naltrexone, an opioid antagonist, is included in the formulation to counteract some opioid side effects and theoretically reduce the rewarding properties that contribute to misuse. The combination aims to maintain analgesic efficacy while improving the safety and tolerability profile compared to oxycodone alone.
Approved indications
- Moderate to severe chronic pain
Common side effects
- Nausea
- Constipation
- Dizziness
- Drowsiness
- Headache
Key clinical trials
- Evaluation of Oral PF614 Relative to OxyContin (PF614-102) (PHASE1)
- A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers (PHASE1)
- A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
- Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone (PHASE1)
- A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted (PHASE1)
- A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery (PHASE3)
- Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers (PHASE1)
- Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers (PHASE1)
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 Naltrexone (b) CI brief — competitive landscape report
- Oxycodone Naltrexone (b) updates RSS · CI watch RSS
- Elite Laboratories, Inc portfolio CI