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Oxycodone/Naltrexone Capsules
Oxycodone/Naltrexone capsules combine an opioid analgesic with an opioid antagonist to provide pain relief while reducing the risk of misuse and dependence.
Oxycodone/Naltrexone capsules combine an opioid analgesic with an opioid antagonist to provide pain relief while reducing the risk of misuse and dependence. Used for Moderate to severe chronic pain where the need for an opioid analgesic is required, and for which alternative treatments are inadequate.
At a glance
| Generic name | Oxycodone/Naltrexone Capsules |
|---|---|
| Sponsor | Elite Laboratories, Inc |
| Drug class | opioid analgesic with abuse-deterrent properties |
| Target | mu-opioid receptors |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Oxycodone acts as a full opioid agonist, binding to mu-opioid receptors to reduce pain perception. Naltrexone, an opioid antagonist, is included at a lower dose to block some of the euphoric effects of oxycodone, thereby reducing the potential for abuse and addiction.
Approved indications
- Moderate to severe chronic pain where the need for an opioid analgesic is required, and for which alternative treatments are inadequate
Common side effects
- Nausea
- Constipation
- Dizziness
Key clinical trials
- Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (PHASE1)
- Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101) (PHASE1)
- A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers (PHASE1)
- 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)
- Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain (PHASE4)
- 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 Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain (PHASE3)
- Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer 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/Naltrexone Capsules CI brief — competitive landscape report
- Oxycodone/Naltrexone Capsules updates RSS · CI watch RSS
- Elite Laboratories, Inc portfolio CI