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Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain.
Postgrad Med. 2016 Jan; 128(1):1-11.PM

Abstract

OBJECTIVES

Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA(®)) delivery technology. Buccal buprenorphine (BBUP; Belbuca(TM), Endo Pharmaceuticals) was evaluated for the management of moderate to severe chronic low back pain (CLBP) requiring around-the-clock analgesia in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-naive patients.

METHODS

Patients (n = 749) were titrated to a dose of BBUP (range, 150-450 µg every 12 h) that was generally well tolerated and provided adequate analgesia for ≥14 days, and then randomized to BBUP (n = 229) or placebo (n = 232), respectively. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in the mean of daily average pain intensity scores (numeric rating scale from 0 [no pain] to 10 [worst pain imaginable]).

RESULTS

Patients were experiencing moderate to severe pain at study entry: mean (SD) = 7.15 (1.05). Following titration, pain was reduced to the mild range; 2.81 (1.07). After randomization, mean (SD) pain scores increased from baseline to week 12 more with placebo (1.59 [2.04]) versus BBUP: (0.94 [1.85]) with a significant between-group difference (-0.67 [95% CI: -1.07 to -0.26]; p = 0.0012). A significantly larger percentage of patients receiving BBUP versus placebo had ≥30% pain reduction (63% vs 47%; p = 0.0012). During double-blind treatment, the most frequent adverse events (AEs) with BBUP were nausea (10%), constipation (4%) and vomiting (4%). The most common AEs with placebo were nausea (7%), upper respiratory tract infection (4%), headache (3%) and diarrhea (3%).

CONCLUSIONS

These findings demonstrate the efficacy and tolerability of BBUP among opioid-naive patients requiring around-the-clock opioid treatment for CLBP.

Authors+Show Affiliations

a Carolinas Pain Institute, Wake Forest Baptist Health , Winston-Salem , NC , USA.b Great Lakes Research Group , Bay City , MI , USA.c Endo Pharmaceuticals Inc ., Malvern , PA , USA.d Clinical Development, Paratek Pharmaceuticals Inc ., Malvern , PA , USA.e BioDelivery Sciences International, Inc ., Raleigh , NC , USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26634956

Citation

Rauck, Richard L., et al. "Efficacy and Tolerability of Buccal Buprenorphine in Opioid-naive Patients With Moderate to Severe Chronic Low Back Pain." Postgraduate Medicine, vol. 128, no. 1, 2016, pp. 1-11.
Rauck RL, Potts J, Xiang Q, et al. Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. Postgrad Med. 2016;128(1):1-11.
Rauck, R. L., Potts, J., Xiang, Q., Tzanis, E., & Finn, A. (2016). Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. Postgraduate Medicine, 128(1), 1-11. https://doi.org/10.1080/00325481.2016.1128307
Rauck RL, et al. Efficacy and Tolerability of Buccal Buprenorphine in Opioid-naive Patients With Moderate to Severe Chronic Low Back Pain. Postgrad Med. 2016;128(1):1-11. PubMed PMID: 26634956.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. AU - Rauck,Richard L, AU - Potts,Jeffrey, AU - Xiang,Qinfang, AU - Tzanis,Evan, AU - Finn,Andrew, Y1 - 2015/12/22/ PY - 2015/12/5/entrez PY - 2015/12/5/pubmed PY - 2016/5/21/medline KW - Buccalbuprenorphine KW - Chronic low back pain KW - Opioid-naive patients SP - 1 EP - 11 JF - Postgraduate medicine JO - Postgrad Med VL - 128 IS - 1 N2 - OBJECTIVES: Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA(®)) delivery technology. Buccal buprenorphine (BBUP; Belbuca(TM), Endo Pharmaceuticals) was evaluated for the management of moderate to severe chronic low back pain (CLBP) requiring around-the-clock analgesia in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-naive patients. METHODS: Patients (n = 749) were titrated to a dose of BBUP (range, 150-450 µg every 12 h) that was generally well tolerated and provided adequate analgesia for ≥14 days, and then randomized to BBUP (n = 229) or placebo (n = 232), respectively. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in the mean of daily average pain intensity scores (numeric rating scale from 0 [no pain] to 10 [worst pain imaginable]). RESULTS: Patients were experiencing moderate to severe pain at study entry: mean (SD) = 7.15 (1.05). Following titration, pain was reduced to the mild range; 2.81 (1.07). After randomization, mean (SD) pain scores increased from baseline to week 12 more with placebo (1.59 [2.04]) versus BBUP: (0.94 [1.85]) with a significant between-group difference (-0.67 [95% CI: -1.07 to -0.26]; p = 0.0012). A significantly larger percentage of patients receiving BBUP versus placebo had ≥30% pain reduction (63% vs 47%; p = 0.0012). During double-blind treatment, the most frequent adverse events (AEs) with BBUP were nausea (10%), constipation (4%) and vomiting (4%). The most common AEs with placebo were nausea (7%), upper respiratory tract infection (4%), headache (3%) and diarrhea (3%). CONCLUSIONS: These findings demonstrate the efficacy and tolerability of BBUP among opioid-naive patients requiring around-the-clock opioid treatment for CLBP. SN - 1941-9260 UR - https://www.unboundmedicine.com/medline/citation/26634956/Efficacy_and_tolerability_of_buccal_buprenorphine_in_opioid_naive_patients_with_moderate_to_severe_chronic_low_back_pain_ L2 - http://www.tandfonline.com/doi/full/10.1080/00325481.2016.1128307 DB - PRIME DP - Unbound Medicine ER -