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Oxycodone with an opioid receptor antagonist: A review
Mellar P Davis1, Harold W Goforth2
1Professor of Medicine, Cleveland Clinic Lerner School of Medicine, Case Western Reserve University, Cleveland, Ohio; Director, Clinical Fellowship Program, Palliative Medicine and Supportive Oncology Services, Division of Solid Tumor, Taussig Cancer Institute, The Cleveland Clinic, Cleveland, Ohio.
Journal of Opioid Management
|February 25, 2016
Summary
Combining prolonged-release oxycodone with naloxone effectively reduces constipation in chronic pain patients. This combination offers comparable pain relief to oxycodone alone, with potential benefits for non-cancer pain management.
Area of Science:
- Pharmacology
- Pain Management
- Gastroenterology
Background:
- Opioid antagonists are combined with agonists to enhance pain control, reduce side effects, and deter abuse.
- Prolonged-release (PR) oxycodone and naloxone combination is a tamper-resistant formulation that reduces constipation.
- Previous studies indicate reduced constipation with this combination, but bioequivalence to PR oxycodone is not established.
Purpose of the Study:
- To evaluate the efficacy and safety of combining prolonged-release oxycodone with naloxone.
- To compare the analgesic effects and side effect profiles of the combination product versus PR oxycodone.
- To assess the impact of this combination on constipation in patients with chronic pain.
Main Methods:
- Review of pivotal randomized trials comparing PR oxycodone and PR oxycodone/naloxone.
- Analysis of analgesic efficacy and constipation as a primary outcome.
- Assessment of safety monitoring data from published manuscripts.
Main Results:
- Two noninferiority trials showed equivalent analgesia between PR oxycodone and the combination product at doses below 120 mg/day.
- The combination product demonstrated significant reduction in constipation compared to PR oxycodone.
- An analgesic ceiling effect was observed above 80-120 mg/day for oxycodone.
- Safety monitoring details were not consistently well-described in published studies.
Conclusions:
- The combination of PR oxycodone and naloxone provides effective pain relief comparable to PR oxycodone alone.
- This combination offers a significant benefit in managing opioid-induced constipation, particularly in chronic non-cancer pain.
- Further research is needed to fully establish bioequivalence and comprehensively describe safety profiles.