Safety And Efficacy Of The Unique Opioid Buprenorphine For The Treatment Of Chronic Pain
Authors Pergolizzi Jr JV, Raffa RB
Received 21 September 2019
Accepted for publication 1 November 2019
Published 13 December 2019 Volume 2019:12 Pages 3299—3317
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Michael A Überall
Joseph V Pergolizzi Jr,1,2 Robert B Raffa3,4
1NEMA Research, Inc., Naples, FL, USA; 2Neumentum, Palo Alto, CA, USA; 3University of Arizona College of Pharmacy, Tucson, AZ, USA; 4Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, PA, USA
Correspondence: Joseph V Pergolizzi Jr
NEMA Research, Inc., 868 106th Ave. North, Naples, FL 34108, USA
Tel +1 239-597-3564
Fax +1 239-908-4436
Background: Chronic pain is associated with decreased quality of life and is one of the most common reasons adults seek medical care, making treatment imperative for many aspects of patient well-being. Chronic pain management typically involves the use of Schedule II full μ-opioid receptor agonists for pain relief; however, the increasing prevalence of opioid addiction is a national crisis that is impacting public health and social and economic welfare. Buprenorphine is a Schedule III partial μ-opioid receptor agonist that is an equally effective but potentially safer treatment option for chronic pain than full μ-opioid receptor agonists. The purpose of this review is to provide an overview of the clinical efficacy and safety of the transdermal and buccal formulations of buprenorphine, which are approved by the Food and Drug Administration for chronic pain, compared with that of extended-release full μ-opioid receptor agonists.
Methods: Controlled or randomized controlled clinical trial information was retrieved from EMBASE, Medline, and PubMed using the search terms “buprenorphine” AND “chronic” AND “pain.”
Results: A total of 33 clinical studies were ultimately used in this review, including 29 (88%) on transdermal buprenorphine and 4 (12%) on buprenorphine buccal film. Although the measure of pain intensity varied among studies, each of these 33 trials demonstrated efficacy for buprenorphine in pain relief. A total of 28 studies also assessed safety, with each concluding that buprenorphine was generally well tolerated.
Conclusion: Comparison of current clinical data along with results of responder and safety analyses support the use of buprenorphine over full μ-opioid receptor agonists for effective preferential treatment of chronic pain; however, head-to-head clinical studies are warranted.
Keywords: opioids, Schedule III, partial μ-opioid receptor agonist
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