title: Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study.
abstract: In this enriched design study, 1,160 opioid-experienced patients with chronic, moderate to severe low back pain entered an open-label run-in period; 660 demonstrated analgesic benefit from and tolerability to buprenorphine transdermal system 20 mcg/hour (BTDS 20) treatment and were randomized to receive either BTDS 20, BTDS 5 mcg/hour (BTDS 5), or the active control (immediate release oxycodone 40-mg/day) during an 84-day double-blind phase. The primary endpoint, "average pain in the last 24 hours" during double-blind weeks 4, 8, and 12, was significantly lower for patients receiving BTDS 20 compared with patients receiving BTDS 5 (P < .001, treatment difference of -.67). A treatment difference of -.75 in favor of oxycodone 40 mg/day versus BTDS 5 (P < .001) indicated the assay sensitivity of the study. Four sensitivity analyses, secondary, and exploratory analyses supported the results of the primary analysis. Incidences of treatment-emergent adverse events were 56% during the open-label period, and 59, 77, and 73% for the BTDS 5, BTDS 20, and oxycodone 40 mg/day treatment groups, respectively, during the double-blind phase. One death considered unrelated to study treatment occurred in a patient receiving BTDS 10 during the run-in period. BTDS 20 treatment was demonstrated to be efficacious and generally well tolerated.
  
  
  CONCLUSIONS
  This article presents results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine (BTDS). In this active controlled, superiority study with an enriched design, BTDS 20 was found to be efficacious and generally well tolerated.
authors.affiliation: Medical Research, Purdue Pharma, LP, Stamford, Connecticut 06901, USA. Deborah.Steiner@pharma.com
authors.forename: Deborah
authors.initials: D
authors.lastname: Steiner
authors.forename: Catherine
authors.initials: C
authors.lastname: Munera
authors.forename: Martin
authors.initials: M
authors.lastname: Hale
authors.forename: Steven
authors.initials: S
authors.lastname: Ripa
authors.forename: Craig
authors.initials: C
authors.lastname: Landau
mesh_terms: D000279:Administration, Cutaneous; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects; D059350:Chronic Pain / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000627:therapeutic use; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine; D010098:Oxycodone