Oxycodone with an opioid receptor antagonist: A review

Mellar P. Davis, MD, FCCP, FAAHPM; Harold W. Goforth, MD

doi:10.5055/jom.2016.0313

Authors

Mellar P. Davis, MD, FCCP, FAAHPM
Harold W. Goforth, MD

DOI:

https://doi.org/10.5055/jom.2016.0313

Keywords:

oxycodone, naloxone, constipation

Abstract

The rationale for putting opioid antagonists with an agonist is to improve pain control, to reduce side effects, and/or to reduce abuse. The combination of prolonged release (PR) oxycodone and naloxone reduces constipation as demonstrated in multiple studies and has been designated a tamper-resistant opioid by the Food and Drug Administration. Bioequivalence of the combination product compared with PR oxycodone has not been established. Several of the pivotal studies provided suboptimal laxative support in the control arm of the randomized trials. Two noninferiority trials have demonstrated equivalent analgesia between PR oxycodone and the combination product at doses of less than 120 mg of oxycodone per day. There appears to be an analgesic ceiling above 80-120 mg of oxycodone per day. Safety monitoring during randomized trials was not been well described in published manuscripts. Benefits appear to be better for those with chronic noncancer pain compared with individuals with cancer when constipation was the primary outcome.

Author Biographies

Mellar P. Davis, MD, FCCP, FAAHPM

Professor 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

Harold W. Goforth, MD

Center for Neurological Restoration, Cleveland Clinic, Neurological Institute, Cleveland, Ohio.

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