Poster –
Buprenorphine Buccal Film for Chronic Low Back Pain in 2 Double-blind, Placebo-controlled, Randomized Withdrawal Trials:
A Pooled Analysis of Subgroups Based on Baseline Pain Severity
Mancia Ko, PharmD1; Gary Cutter, PhD2,3; Todd Kunkel, PharmD1
1 BioDelivery Sciences International, Inc., Raleigh, NC, USA; 2 Pythagoras, Inc., Birmingham, AL, USA; 3 University of Alabama at Birmingham School of Public Health, Department of Biostatistics, Birmingham, AL, USA
Buprenorphine Buccal Film (BELBUCA®)
- Buprenorphine is an atypical opioid and a partial µ-opioid receptor agonist, with demonstrated efficacy as an analgesic and favorable safety properties that may provide an improved risk-benefit profile relative to other opioids1
- As with all Schedule II long-acting opioids, buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate2
- Two previous phase 3 clinical trials established the efficacy of BBF for treating chronic low back pain in opioid-naive3 and opioid-experienced4 subjects (ClinicalTrials.gov NCT01633944 and NCT01675167, respectively)
- Both studies used an enriched enrollment, randomized withdrawal design that consisted of an open-label BBF titration phase followed by a randomized, double-blind phase in which subjects either continued treatment with BBF or were switched to placebo3,4 (Figure 1)
- After 12 weeks of double-blind treatment, mean average daily pain scores worsened significantly less from baseline in subjects who continued use of BBF than in those who switched to placebo3,4
- Subjects in the BBF group also had significantly lower pain scores at Week 1 and at all subsequent time points through Week 123,4
Objective
This post hoc analysis pooled data from both aforementioned clinical trials to characterize further the efficacy of BBF on the basis of baseline pain severity
Presentation Slide Handouts: Poster Presentation
DOI: 10-5055-bupe-21-pp-0070
References:
1.Marshall B, et al. Pain Manag. 2019;9(2):131-138.
2.Webster LR, et al. Adv Ther. 2020;37(11):4685-4696.
3.United States Drug Enforcement Administration. Drug scheduling. https://www.dea.gov/drug-scheduling.
4.Belbuca. Package insert. BioDelivery Sciences International, Inc.; 2019.
5.Webster LR, et al. Pain Med. 2016;17(6):1112-1130.
6.Kopecky EA, et al. J Clin Pharmacol. 2017;57(4):500-512.
7.Shram MJ, et al. J Clin Psychopharmacol. 2015;35(3):242-9.