Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain

References

• Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10:113–130.
   PubMed Web of Science ®Google Scholar
• Johannes CB, Le TK, Zhou X, et al. The prevalence of chronic pain in United States adults: results of an Internet-based survey. J Pain. 2010;11:1230–1239.
   PubMed Web of Science ®Google Scholar
• Nahin RL. Estimates of pain prevalence and severity in adults: United States, 2012. J Pain. 2015;16:769–780.
   PubMed Web of Science ®Google Scholar
• Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012;13:715–724.
   PubMed Web of Science ®Google Scholar
• Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64:2028–2037.
   PubMed Web of Science ®Google Scholar
• Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478–491.
   PubMed Web of Science ®Google Scholar
• Deyo RA, Von Korff M, Duhrkoop D. Opioids for low back pain. Bmj. 2015;350:g6380.
   PubMed Web of Science ®Google Scholar
• Cicero TJ, Ellis MS, Surratt HL, et al. Factors influencing the selection of hydrocodone and oxycodone as primary opioids in substance abusers seeking treatment in the United States. Pain. 2013;154:2639–2648.
   PubMed Web of Science ®Google Scholar
• Vowles KE, McEntee ML, Julnes PS, et al. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015;156:569–576.
   PubMed Web of Science ®Google Scholar
• Gammaitoni AR, Smugar SS, Jensen MP, et al. Predicting response to pregabalin from pretreatment pain quality: clinical applications of the pain quality assessment scale. Pain Med. 2013;14:526–532.
   PubMed Web of Science ®Google Scholar
• Manchikanti L, Helm S 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain Physician. 2012;15:ES9–ES38.
   PubMed Web of Science ®Google Scholar
• Pergolizzi J, Aloisi AM, Dahan A, et al. Current knowledge of buprenorphine and its unique pharmacological profile. Pain Pract. 2010;10:428–450.
   PubMed Web of Science ®Google Scholar
• Koppert W, Ihmsen H, Korber N, et al. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005;118:15–22.
   PubMed Web of Science ®Google Scholar
• Davis MP. Twelve reasons for considering buprenorphine as a frontline analgesic in the management of pain. J Support Oncol. 2012;10:209–219.
   PubMedGoogle Scholar
• Wolff RF, Aune D, Truyers C, et al. Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain. Curr Med Res Opin. 2012;28:833–845.
   PubMed Web of Science ®Google Scholar
• Cowan A, Lewis JW, Macfarlane IR. Agonist and antagonist properties of buprenorphine, a new antinociceptive agent. Br J Pharmacol. 1977;60:537–545.
   PubMed Web of Science ®Google Scholar
• Budd K. High dose buprenorphine for postoperative analgesia. Anaesthesia. 1981;36:900–903.
   PubMed Web of Science ®Google Scholar
• Christoph T, Kogel B, Schiene K, et al. Broad analgesic profile of buprenorphine in rodent models of acute and chronic pain. Eur J Pharmacol. 2005;507:87–98.
   PubMed Web of Science ®Google Scholar
• Sittl R, Likar R, Nautrup BP. Equipotent doses of transdermal fentanyl and transdermal buprenorphine in patients with cancer and noncancer pain: results of a retrospective cohort study. Clin Ther. 2005;27:225–237.
   PubMed Web of Science ®Google Scholar
• Butrans® (buprenorphine). Full prescribing information [package insert]. Stamford (CT): Purdue Pharma L.P.; 2014.
   Google Scholar
• Steiner D, Munera C, Hale M, et al. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011;12:1163–1173.
   PubMed Web of Science ®Google Scholar
• Steiner DJ, Sitar S, Wen W, et al. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011;42:903–917.
   PubMed Web of Science ®Google Scholar
• Finn A, Bai S, Xiang Q. An evaluation of the bioavailability and dose linearity of BEMA® buprenorphine buccal film in healthy subjects [poster abstract]. Postgrad Med. 2014;41–42.
   Google Scholar
• Finn A, Bai S, Xiang Q. An evaluation of the pharmacokinetics, safety, and tolerability of BEMA® buprenorphine following multiple-dose administration in healthy subjects [poster abstract]. Postgrad Med. 2014;42–43.
   Google Scholar
• Roland M, Fairbank J. The Roland-Morris disability questionnaire and the Oswestry disability questionnaire. Spine (Phila Pa 1976). 2000;25:3115–3124.
   PubMed Web of Science ®Google Scholar
• Benyamin R, Trescot AM, Datta S, et al. Opioid complications and side effects. Pain Physician. 2008;11:S105–S120.
   PubMed Web of Science ®Google Scholar
• Manchikanti L, Damron KS, McManus CD, et al. Patterns of illicit drug use and opioid abuse in patients with chronic pain at initial evaluation: a prospective, observational study. Pain Physician. 2004;7:431–437.
   PubMedGoogle Scholar
• Huang P, Kehner GB, Cowan A, et al. Comparison of pharmacological activities of buprenorphine and norbuprenorphine: norbuprenorphine is a potent opioid agonist. J Pharmacol Exp Ther. 2001;297:688–695.
   PubMed Web of Science ®Google Scholar
• Ciccocioppo R, Angeletti S, Sanna PP, et al. Effect of nociceptin/orphanin FQ on the rewarding properties of morphine. Eur J Pharmacol. 2000;404:153–159.
   PubMed Web of Science ®Google Scholar
• Ciccocioppo R, Angeletti S, Panocka I, et al. Nociceptin/orphanin FQ and drugs of abuse. Peptides. 2000;21:1071–1080.
   PubMed Web of Science ®Google Scholar
• Walsh SL, Preston KL, Bigelow GE, et al. Acute administration of buprenorphine in humans: partial agonist and blockade effects. J Pharmacol Exp Ther. 1995;274:361–372.
   PubMed Web of Science ®Google Scholar
• Walsh SL, Eissenberg T. The clinical pharmacology of buprenorphine: extrapolating from the laboratory to the clinic. Drug Alcohol Depend. 2003;70:S13–S27.
   PubMed Web of Science ®Google Scholar
• Jasinski DR, Pevnick JS, Griffith JD. Human pharmacology and abuse potential of the analgesic buprenorphine: a potential agent for treating narcotic addiction. Arch Gen Psychiatry. 1978;35:501–516.
   PubMed Web of Science ®Google Scholar
• Robinson SE. Buprenorphine: an analgesic with an expanding role in the treatment of opioid addiction. CNS Drug Rev. 2002;8:377–390.
   PubMedGoogle Scholar
• Tompkins DA, Smith MT, Mintzer MZ, et al. A double blind, within subject comparison of spontaneous opioid withdrawal from buprenorphine versus morphine. J Pharmacol Exp Ther. 2014;348:217–226.
   PubMed Web of Science ®Google Scholar
• Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63:649–671.
   PubMed Web of Science ®Google Scholar
• Hale M, Khan A, Kutch M, et al. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010;26:1505–1518.
   PubMed Web of Science ®Google Scholar
• Hyup Lee J, Lee CS, Ultracet ER Study Group. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain. Clin Ther. 2013;35:1830–1840.
   PubMed Web of Science ®Google Scholar
• Kalso E, Edwards JE, Moore RA, et al. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112:372–380.
   PubMed Web of Science ®Google Scholar
• Rauck RL, Nalamachu S, Wild JE, et al. Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study. Pain Med. 2014;15:975–985.
   PubMed Web of Science ®Google Scholar
• Annemans L. Pharmacoeconomic impact of adverse events of long-term opioid treatment for the management of persistent pain. Clin Drug Investig. 2011;31:73–86.
   PubMed Web of Science ®Google Scholar
• Peniston JH, Gould E. Oxymorphone extended release for the treatment of chronic low back pain: a retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use. Clin Ther. 2009;31:347–359.
   PubMed Web of Science ®Google Scholar
• Tassinari D, Drudi F, Rosati M, et al. Transdermal opioids as front line treatment of moderate to severe cancer pain: a systemic review. Palliat Med. 2011;25:478–487.
   PubMed Web of Science ®Google Scholar
• Dahan A, Yassen A, Bijl H, et al. Comparison of the respiratory effects of intravenous buprenorphine and fentanyl in humans and rats. Br J Anaesth. 2005;94:825–834.
   PubMed Web of Science ®Google Scholar
• Finn A, Bai SA, Xiang Q An evaluation of the bioavailability and dose linearity of BEMA® buprenorphine buccal film in healthy subjects. Presented at: PAINWeek; 2014 Sep 2–6; Las Vegas, NV.
   Google Scholar
• Yassen A, Olofsen E, Van Dorp E, et al. Mechanism-based pharmacokinetic-pharmacodynamic modelling of the reversal of buprenorphine-induced respiratory depression by naloxone: a study in healthy volunteers. Clin Pharmacokinetic. 2007;46:965–980.
   PubMed Web of Science ®Google Scholar
• Van Dorp E, Yassen A, Sarton E, et al. Naloxone reversal of buprenorphine-induced respiratory depression. Anesthesiology. 2006;105:51–57.
   PubMed Web of Science ®Google Scholar
• Gimbel J, Spierings E, Katz N, et al. Efficacy and tolerability of BEMA buprenorphine in opioid-experienced patients with moderate-to-severe chronic low back pain: primary results from a phase 3, enriched-enrollment, randomized withdrawal study. J Pain. 2015;16:S85.
   Web of Science ®Google Scholar
• Katz N, Rauck R, Ahdieh H, et al. A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain. Curr Med Res Opin. 2007;23:117–128.
   PubMed Web of Science ®Google Scholar
• Kwong WJ, Diels J, Kavanagh S. Costs of gastrointestinal events after outpatient opioid treatment for non-cancer pain. Ann Pharmacother. 2010;44:630–640.
   PubMed Web of Science ®Google Scholar
• Gimbel J, Spierings E, Katz N, et al. Efficacy and tolerability of BEMA buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a phase 3, enriched enrollment, randomized withdrawal study. Presented at: American Pain Society Annual Meeting; 2015 May 13–16; Palm Springs, CA
   Google Scholar