PMID- 26634956 OWN - NLM STAT- MEDLINE DCOM- 20160520 LR - 20220317 IS - 1941-9260 (Electronic) IS - 0032-5481 (Linking) VI - 128 IP - 1 DP - 2016 Jan TI - Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. PG - 1-11 LID - 10.1080/00325481.2016.1128307 [doi] AB - OBJECTIVES: Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA((R))) 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 microg 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. FAU - Rauck, Richard L AU - Rauck RL AD - a Carolinas Pain Institute, Wake Forest Baptist Health , Winston-Salem , NC , USA. FAU - Potts, Jeffrey AU - Potts J AD - b Great Lakes Research Group , Bay City , MI , USA. FAU - Xiang, Qinfang AU - Xiang Q AD - c Endo Pharmaceuticals Inc ., Malvern , PA , USA. FAU - Tzanis, Evan AU - Tzanis E AD - d Clinical Development, Paratek Pharmaceuticals Inc ., Malvern , PA , USA. FAU - Finn, Andrew AU - Finn A AD - e BioDelivery Sciences International, Inc ., Raleigh , NC , USA. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20151222 PL - England TA - Postgrad Med JT - Postgraduate medicine JID - 0401147 RN - 0 (Analgesics, Opioid) RN - 40D3SCR4GZ (Buprenorphine) SB - IM MH - Administration, Buccal MH - Adult MH - Aged MH - Aged, 80 and over MH - Analgesics, Opioid/*administration & dosage/therapeutic use MH - Buprenorphine/*administration & dosage/therapeutic use MH - Chronic Pain/diagnosis/*drug therapy MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - Low Back Pain/diagnosis/*drug therapy MH - Male MH - Middle Aged MH - Pain Measurement MH - Severity of Illness Index MH - Treatment Outcome OTO - NOTNLM OT - Buccalbuprenorphine OT - Chronic low back pain OT - Opioid-naive patients EDAT- 2015/12/05 06:00 MHDA- 2016/05/21 06:00 CRDT- 2015/12/05 06:00 PHST- 2015/12/05 06:00 [entrez] PHST- 2015/12/05 06:00 [pubmed] PHST- 2016/05/21 06:00 [medline] AID - 10.1080/00325481.2016.1128307 [doi] PST - ppublish SO - Postgrad Med. 2016 Jan;128(1):1-11. doi: 10.1080/00325481.2016.1128307. Epub 2015 Dec 22.