The Potential Role of an Extended-Release, Abuse-Deterrent Oxycodone/Acetaminophen Fixed-Dose Combination Product for the Treatment of Acute Pain.

Joseph V Pergolizzi,Robert Taylor,Robert B Raffa

doi:10.1007/s12325-015-0213-5

Abstract

Acute pain, prevalent as part of postoperative and traumatic pain, is often sub-optimally or inadequately treated. Fixed-dose combination analgesic products that combine a reduced amount of opioid with a nonopioid analgesic such as acetaminophen (paracetamol) in a single tablet offer potential pharmacodynamic and/or pharmacokinetic benefits, and may also result in an opioid-sparing effect. A new analgesic product (XARTEMIS™ XR, Mallinckrodt Brand Pharmaceuticals, Dublin, Ireland) combines oxycodone (7.5 mg) with acetaminophen (325 mg) in an immediate-release/extended-release (ER) formulation that is indicated for the treatment of acute pain. The ER formulation of this product provides stable serum drug concentrations that in this case lasts 12 h. Oxycodone/acetaminophen is a drug combination that offers safe and effective pain relief in a variety of acute pain syndromes such as postoperative pain. The combination formulation allows a smaller amount of oxycodone per tablet and the biphasic-layered matrix of the pill for ER may present obstacles to potential abusers. No opioid is totally abuse resistant, but the lower opioid content and tamper-resistant formulation of this product might discourage abuse. Clinicians must still be mindful of the acetaminophen part of this product in the patient’s overall daily intake (in light of acetaminophen hepatotoxicity). The new product appears to provide an important new choice in the armamentarium against acute pain.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0213-5) contains supplementary material, which is available to authorized users.

Highlights

A new analgesic product (XARTEMISTM XR, Mallinckrodt Brand Pharmaceuticals, Dublin, Ireland) combines oxycodone (7.5 mg) with acetaminophen (325 mg) in an immediaterelease/extended-release (ER) formulation that is indicated for the treatment of acute pain
Acute pain is prevalent and often under-treated [1, 2] that results in increased suffering and distress, delayed rehabilitation and healing, and may transition to chronic pain [3, 4]
As a Schedule II controlled substance, this new oxycodone/ acetaminophen product will be closely regulated and it lacks some of the features that make opioid analgesics ‘‘likeable’’ in the eyes of potential abusers

Summary

Introduction

Acute pain is prevalent and often under-treated [1, 2] that results in increased suffering and distress, delayed rehabilitation and healing, and may transition to chronic pain (a process known as chronification) [3, 4]. A new analgesic product (XARTEMISTM XR, Mallinckrodt Brand Pharmaceuticals, Dublin, Ireland) combines oxycodone (7.5 mg) with acetaminophen (325 mg) in an immediaterelease/extended-release (ER) formulation that is indicated for the treatment of acute pain. XARTEMISTM XR (previously known as MNK795, Mallinckrodt Brand Pharmaceuticals, Dublin, Ireland), is the first immediate-release (IR)/extended-release (ER) abuse-deterrent formulation comprised of a fixed-dose combination of oxycodone (7.5 mg) plus acetaminophen (325 mg) that is available on the market.

Results

Conclusion