title: Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain.
abstract: OBJECTIVE
  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.affiliation: a Carolinas Pain Institute, Wake Forest Baptist Health , Winston-Salem , NC , USA.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Rauck
authors.affiliation: b Great Lakes Research Group , Bay City , MI , USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Potts
authors.affiliation: c Endo Pharmaceuticals Inc ., Malvern , PA , USA.
authors.forename: Qinfang
authors.initials: Q
authors.lastname: Xiang
authors.affiliation: d Clinical Development, Paratek Pharmaceuticals Inc ., Malvern , PA , USA.
authors.forename: Evan
authors.initials: E
authors.lastname: Tzanis
authors.affiliation: e BioDelivery Sciences International, Inc ., Raleigh , NC , USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Finn
mesh_terms: D000278:Administration, Buccal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000627:therapeutic use; D002047:Buprenorphine / Q000008:administration & dosage* / Q000627:therapeutic use; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine
keywords: Buccalbuprenorphine; Chronic low back pain; Opioid-naive patients