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Management of moderate to severe chronic low back pain with buprenorphine buccal film using novel bioerodible mucoadhesive technology

Authors Pergolizzi Jr JV, Raffa RB, Fleischer C, Zampogna G, Taylor R Jr

Received 5 May 2016

Accepted for publication 22 June 2016

Published 31 October 2016 Volume 2016:9 Pages 909—916

DOI https://doi.org/10.2147/JPR.S87952

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Colin Mak

Peer reviewer comments 2

Editor who approved publication: Dr Michael E Schatman


Joseph V Pergolizzi Jr,1 Robert B Raffa,2,3 Charles Fleischer,1 Gianpietro Zampogna,1 Robert Taylor Jr1

1NEMA Research, Naples, FL, 2University of Arizona College of Pharmacy, Tucson, AZ, 3Temple University School of Pharmacy, Philadelphia, PA, USA


Abstract: With a global prevalence of ~9%–12%, low back pain (LBP) is a serious public health issue, associated with high costs for treatment and lost productivity. Chronic LBP (cLBP) involves central sensitization, a neuropathic pain component, and may induce maladaptive coping strategies and depression. Treating cLBP is challenging, and current treatment options are not fully satisfactory. A new BioErodible MucoAdhesive (BEMA®) delivery system for buprenorphine has been developed to treat cLBP. The buccal buprenorphine (BBUP) film developed for this product (Belbuca™) allows for rapid delivery and titration over a greater range of doses than was previously available with transdermal buprenorphine systems. In clinical studies, BBUP was shown to effectively reduce pain associated with cLBP at 12 weeks with good tolerability. The most frequently reported side effects with the use of BBUP were nausea, constipation, and vomiting. There was no significant effect on the QT interval vs placebo. Chronic pain patients using other opioids can be successfully rotated to BBUP without risk of withdrawal symptoms or inadequate analgesia. The role of BBUP in managing cLBP remains to be determined, but it appears to be a promising new product in the analgesic arsenal in general.

Keywords: buccal, transmucosal, buprenorphine, chronic low back pain, BEMA, drug delivery Belbuca

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