Use of immediate-release opioids as supplemental analgesia during management of moderate-to-severe chronic pain with buprenorphine transdermal system

Abstract

Background

The buprenorphine transdermal system (BTDS) is approved in the US for the management of chronic pain. Due to its high affinity for μ-opioid receptors with a slow dissociation profile, buprenorphine may potentially displace or prevent the binding of competing μ-opioid-receptor agonists, including immediate-release (IR) opioids, in a dose-dependent manner. Health care professionals may assume that the use of IR opioids for supplemental analgesia during BTDS therapy is not acceptable.

Materials and methods

This post hoc analysis evaluated the use of IR opioids as supplemental analgesia during the management of moderate–severe chronic pain with BTDS at 52 US sites (BUP3015S, NCT01125917). Patients were categorized into IR-opioid and no-IR-opioid groups. At each visit of the extension phase, adverse events, concomitant medications, and information from the Brief Pain Inventory (BPI) were recorded.

Results

The most common supplemental IR opioids prescribed during BTDS treatment (n=354) were hydrocodone–acetaminophen and oxycodone–acetaminophen. The mean daily dose of IR opioids (morphine equivalents) for supplemental analgesia was 22 mg. At baseline, BPI – pain intensity and BPI – interference scores were higher for patients in the IR-opioid group. In both treatment groups, scores improved by week 4, and then were maintained throughout 6 months of the open-label extension trial. The incidence of treatment-emergent adverse events was similar in both groups.

Conclusion

Patients who were prescribed IR opioids reported lower scores for BPI pain intensity and pain interference to levels similar to patients receiving BTDS without IR opioids, without increasing the rate or severity of treatment-emergent adverse events. Patients prescribed concomitant use of IR opioids with BTDS had greater treatment persistence. The results of this post hoc analysis provide support for the concomitant use of IR opioids for supplemental analgesia during the management of moderate–severe chronic pain with BTDS.

Keywords:

• buprenorphine transdermal system
• ER opioids
• chronic low-back pain
• chronic noncancer pain
• Butrans
• supplemental analgesia
• breakthrough pain

Acknowledgments

This research was supported by funding from Purdue Pharma LP. The authors thank colleagues Ellie He and Zhai Qiang from Purdue Pharma who provided biostatistical expertise that assisted the research.

Author contributions

All authors were involved in study design and data collection, and participated in data analysis, data interpretation, and writing the article. The authors had full access to all data, and had final responsibility for the decision to submit for publication.

Disclosure

MJC, MK, and SRR are full-time employees of Purdue Pharma LP. SS is a speaker/consultant for Purdue Pharma and other companies. RBR is a speaker, consultant, and basic-science investigator for several pharmaceutical companies involved in analgesics research, but receives no royalty from the sale of any product. The abstract of this paper was presented at the American Pharmacists Association Annual Meeting and Exposition, March 9–12, 2012, New Orleans, LA as an abstract with interim findings, and then at the following conferences as posters: Pain Week, September 6–10, 2012, Las Vegas, NV; American Academy of Pain Management 23rd Annual Clinical Meeting, September 20–23, 2012, Phoenix, AZ.