The Implications of Tamper–Resistant Formulations for Opioid Rotation

References

• . Centers for Disease Control and Prevention, National Center for Health Statistics. New report finds pain affects millions of Americans [press release]. http://www.cdc.gov/media/pressrel/r061115.htm?s_cid=mediarel_r061115. Released November 15, 2006. Accessed July 19, 2012
   Google Scholar
• . Chou R, Fanciullo GJ, Fine PG, ; American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113–130
   Google Scholar
• . Zhang W, Moskowitz RW, Nuki G, . OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137–162
   PubMed Web of Science ®Google Scholar
• . Chou R, Qaseem A, Snow V, ; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. 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(7):478–491
   PubMed Web of Science ®Google Scholar
• . American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009;57(8): 1331–1346
   PubMed Web of Science ®Google Scholar
• . National Center for Health Statistics. Health, United States, 2007. With Chartbook on Trends in the Health of Americans. Hyattsville, MD: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 2007
   Google Scholar
• . Sellers EM, Schoedel KA, Romach MK. Update on formulations to deter tampering. Presented at: 73rd Annual Scientific Meeting of the College on Problems of Drug Dependence; June 18–23, 2011; Hollywood, FL
   Google Scholar
• . Grilo RM, Bertin P, Scotto di Fazano C, . Opioid rotation in the treatment of joint pain. A review of 67 cases. Joint Bone Spine. 2002; 69(5):491–494
   PubMed Web of Science ®Google Scholar
• . Mercadante S, Bruera E. Opioid switching: a systematic and critical review. Cancer Treat Rev. 2006;32(4):304–315
   PubMed Web of Science ®Google Scholar
• . Quang–Cantagrel ND, Wallace MS, Magnuson SK. Opioid substitution to improve the effectiveness of chronic noncancer pain control: a chart review. Anesth Analg. 2000;90(4):933–937
   PubMed Web of Science ®Google Scholar
• . Slatkin NE. Opioid switching and rotation in primary care: implementation and clinical utility. Curr Med Res Opin. 2009;25(9):2133–2150
   PubMed Web of Science ®Google Scholar
• . Thomsen AB, Becker N, Eriksen J. Opioid rotation in chronic non-malignant pain patients. A retrospective study. Acta Anaesthesiol Scand. 1999;43(9):918–923
   PubMed Web of Science ®Google Scholar
• . Barkin RL, Iasco AM, Barkin SJ. Opioids used in primary care for the management of pain: a pharmacologic, pharmacotherapeutic, and pharmacodynamic overview. In: Boswell M V, Cole BE, eds. Weiner's Pain Management: A Practical Guide for Clinicians. 7th ed. New York, NY: Taylor and Francis; 2005:789–804
   Google Scholar
• . Lötsch J, Geisslinger G. Relevance of frequent mu-opioid receptor polymorphisms for opioid activity in healthy volunteers. Pharmacogenomics J. 2006;6(3):200–210
   PubMed Web of Science ®Google Scholar
• . Pan L, Xu J, Yu R, Xu MM, Pan YX, Pasternak GW. Identification and characterization of six new alternatively spliced variants of the human mu opioid receptor gene, Oprm. Neuroscience. 2005;133(1):209–220
   PubMed Web of Science ®Google Scholar
• . Pan YX, Xu J, Mahurter L, Bolan E, Xu M, Pasternak GW. Generation of the mu opioid receptor (MOR-1) protein by three new splice variants of the Oprm gene. Proc Natl Acad Sci USA. 2001;98(24): 14084–14089
   PubMed Web of Science ®Google Scholar
• . Pan YX, Xu J, Mahurter L, Xu M, Gilbert AK, Pasternak GW. Identification and characterization of two new human mu opioid receptor splice variants, hMOR-1O and hMOR-1X. Biochem Biophys Res Commun. 2003;301(4):1057–1061
   PubMed Web of Science ®Google Scholar
• . Reyes–Gibby CC, Shete S, Rakvåg T, . Exploring joint effects of genes and the clinical efficacy of morphine for cancer pain: OPRM1 and COMT gene. Pain. 2007;130(1–2):25–30
   PubMed Web of Science ®Google Scholar
• . Viganó A, Bruera E, Suarez–Almazor ME. Age, pain intensity, and opioid dose in patients with advanced cancer. Cancer. 1998;83(6):1244–1250
   PubMed Web of Science ®Google Scholar
• . Cepeda MS, Farrar JT, Baumgarten M, Boston R, Carr DB, Strom BL. Side effects of opioids during short-term administration: effect of age, gender, and race. Clin Pharmacol Ther. 2003;74(2):102–112
   PubMed Web of Science ®Google Scholar
• . Gear RW, Miaskowski C, Gordon NC, Paul SM, Heller PH, Levine JD. Kappa-opioids produce significantly greater analgesia in women than in men. Nat Med. 1996;2(11):1248–1250
   PubMed Web of Science ®Google Scholar
• . Murtagh FE, Chai MO, Donohoe P, Edmonds PM, Higginson IJ. The use of opioid analgesia in end-stage renal disease patients managed without dialysis: recommendations for practice. J Pain Palliat Care Pharmacother. 2007;21(2):5–16
   PubMedGoogle Scholar
• . Tegeder I, Lötsch J, Geisslinger G. Pharmacokinetics of opioids in liver disease. Clin Pharmacokinet. 1999;37(1):17–40
   PubMed Web of Science ®Google Scholar
• . Smith HS. Opioid metabolism. Mayo Clin Proc. 2009;84(7):613–624
   PubMed Web of Science ®Google Scholar
• . Narabayashi M, Saijo Y, Takenoshita S, ; Advisory Committee for Oxycodone Study. Opioid rotation from oral morphine to oral oxycodone in cancer patients with intolerable adverse effects: an open-label trial. Jpn J Clin Oncol. 2008;38(4):296–304
   PubMed Web of Science ®Google Scholar
• . Riley J, Ross JR, Rutter D, . No pain relief from morphine? Individual variation in sensitivity to morphine and the need to switch to an alternative opioid in cancer patients. Support Care Cancer. 2006; 14(1):56–64
   PubMed Web of Science ®Google Scholar
• . Morita T, Takigawa C, Onishi H, ; Japan Pain, Rehabilitation, Palliative Medicine, and Psycho-Oncology (PRPP) Study Group. Opioid rotation from morphine to fentanyl in delirious cancer patients: an open-label trial. J Pain Symptom Manage. 2005;30(1): 96–103
   PubMed Web of Science ®Google Scholar
• . Hale ME, Ahdieh H, Ma T, Rauck R; Oxymorphone ER Study Group 1. Efficacy and safety of OPANA ER (oxymorphone extended release) for relief of moderate to severe chronic low back pain in opioid-experienced patients: a 12-week, randomized, double-blind, placebo-controlled study. J Pain. 2007;8(2):175–184
   PubMed Web of Science ®Google Scholar
• . Korkmazsky M, Ghandehari J, Sanchez A, Lin HM, Pappagallo M. Feasibility study of rapid opioid rotation and titration. Pain Physician. 2011;14(1):71–82
   PubMed Web of Science ®Google Scholar
• . Rappaport BA. New Drug Application Approval Letter. Silver Spring, MD: US Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201655Orig1s000Ltr.pdf. December 9, 2011
   Google Scholar
• . Stanos SP, Bruckenthal P, Barkin RL. Strategies to reduce the tampering and subsequent abuse of long-acting opioids: potential risks and benefits of formulations with physical or pharmacologic deterrents to tampering. Mayo Clin Proc. 2012;87(7):683–694
   PubMed Web of Science ®Google Scholar
• . Passik SD, Hays L, Eisner N, Kirsh KL. Psychiatric and pain characteristics of prescription drug abusers entering drug rehabilitation. J Pain Palliat Care Pharmacother. 2006;20(2):5–13
   PubMedGoogle Scholar
• . US Food and Drug Administration; US Department of Health and Human Services. FDA approves new formulation for OxyContin [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207480.htm. Released April 5, 2010. Accessed July 19, 2012
   Google Scholar
• . Purdue Pharma LP. FDA Advisory Committee on reformulated OxyContin. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM249272.pdf. Accessed July 19, 2012
   Google Scholar
• . OxyContin® (oxycodone HCl controlled-release tablets) [package insert]. Stamford, CT: Purdue Pharma L.P.; 2011
   Google Scholar
• . Butler SF, Black RA, Cassidy TA, Dailey TM, Budman SH. Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J. 2011;8(1):29
   PubMed Web of Science ®Google Scholar
• . Katz N. Abuse-deterrent opioid formulations: are they a pipe dream? Curr Rheumatol Rep. 2008;10(1):11–18
   PubMedGoogle Scholar
• . Black R, Coplan P, Cassidy T, . Effects of reformulated OxyContin® among patients assessed for substance abuse treatment in the NAVIP-PRO sentinal surveillance network. J Pain. 2012;13( 4 suppl):S58
   PubMed Web of Science ®Google Scholar
• . Cicero TJ, Ellis MS, Surratt HL. Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 2012;367(2):187–189
   PubMed Web of Science ®Google Scholar
• . Bartholomaeus J, Arkenau–Mari E, Galia E. Opioid extended-release tablets with improved tamper-resistant properties. Expert Opin Drug Deliv. 2012;9(8):879–891
   PubMed Web of Science ®Google Scholar
• . Vosburg SK, Jones JD, Manubay JM, Ashworth JB, Benedek IH, Comer SD. Assessment of a formulation designed to be crush-resistant in prescription opioid abusers [published online ahead of print June 20, 2012]. Drug Alcohol Depend
   Google Scholar
• . Benedek IH, Jobes J, Xiang Q, Fiske WD. Bioequivalence of oxymorphone extended release and crush-resistant oxymorphone extended release. Drug Des Devel Ther. 2011;5:455–463
   PubMed Web of Science ®Google Scholar
• . Katz N, Sun S, Johnson F, Stauffer J. ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety. J Pain. 2010;11(4):303–311
   PubMed Web of Science ®Google Scholar
• . Johnson FK, Stark JG, Bieberdorf FA, Stauffer J. Relative oral bioavailability of morphine and naltrexone derived from crushed morphine sulfate and naltrexone hydrochloride extended-release capsules versus intact product and versus naltrexone solution: a single-dose, randomized-sequence, open-label, three-way crossover trial in healthy volunteers. Clin Ther. 2010;32(6): 1149–1164
   PubMed Web of Science ®Google Scholar
• . Stauffer J, Setnik B, Sokolowska M, Romach M, Johnson F, Sellers E. Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: a randomized, double-blind, placebo-controlled, crossover study. Clin Drug Investig. 2009;29(12): 777–790
   PubMed Web of Science ®Google Scholar
• . Webster LR, Johnson FK, Stauffer J, Setnik B, Ciric S. Impact of intravenous naltrexone on intravenous morphine-induced high, drug liking, and euphoric effects in experienced, nondependent male opioid users. Drugs R D. 2011;11(3):259–275
   PubMedGoogle Scholar
• . Katz N, Hale M, Morris D, Stauffer J. Morphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain. Postgrad Med. 2010;122(4):112–128
   PubMed Web of Science ®Google Scholar
• . Webster LR, Brewer R, Wang C, . Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010;40(5):734–746
   PubMed Web of Science ®Google Scholar
• . Jang DH, Rohe JC, Hoffman RS, Nelson LS. Severe opioid withdrawal due to misuse of new combined morphine and naltrexone product (Embeda). Ann Emerg Med. 2010;55(3):303–304
   PubMed Web of Science ®Google Scholar
• . Ruan X, Chen T, Gudin J, Couch JP, Chiravuri S. Acute opioid withdrawal precipitated by ingestion of crushed Embeda (morphine extended release with sequestered naltrexone): case report and the focused review of the literature. J Opioid Manag. 2010;6(4):300–303
   PubMedGoogle Scholar
• . www.AboutLawsuits.com. Embeda recall issued due to ongoing manufacturing problems. Saiontz and Kirk, PA. http://www.aboutlaw-suits.com/embeda-recall-manufacturing-problems-16891/. Published March 16, 2011. Accessed July 19, 2012
   Google Scholar
• . OXECTA® (oxycodone HCl, USP) [package insert]. Bristol, TN: King Pharmaceuticals, Inc.; 2011
   Google Scholar
• . Butler SF, Benoit C, Budman SH, . Development and validation of an Opioid Attractiveness Scale: a novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct J. 2006;3:5
   PubMedGoogle Scholar
• . Butler SF, Black R, Grimes Serrano JM, Folensbee L, Chang A, Katz N. Estimating attractiveness for abuse of a not-yet-marketed “abuse–deterrent” prescription opioid formulation. Pain Med. 2010;11(1):81–91
   PubMed Web of Science ®Google Scholar
• . Cole C, Jones L, McVeigh J, Kicman A, Syed Q, Bellis M. Adulterants in illicit drugs: a review of empirical evidence. Drug Test Anal. 2011;3(2):89–96
   PubMed Web of Science ®Google Scholar
• . WHO Model List of Essential Medicines. Vol 17. Geneva, Switzerland: The World Health Organization; 2011
   Google Scholar
• . EMBEDA® (morphine sulfate and naltrexone hydrochloride) [package insert]. Bristol, TN: King Pharmaceuticals, Inc.; 2009
   Google Scholar
• . De Lima L. International Association for Hospice and Palliative Care list of essential medicines for palliative care. Ann Oncol. 2007;18(2):395–399
   PubMed Web of Science ®Google Scholar
• . OPANA® ER (oxymorphone hydrochloride) [package insert]. Chadds Ford, PA: Endo Pharmaceuticals Inc.; 2012
   Google Scholar
• . Pergolizzi JV Jr, Wieman MS, Gould EM. Effect of age and sex on the pharmacokinetics and metabolism of oxymorphone extended-release tablet. Presented at: American Geriatrics Society Annual Meeting; May 2–5, 2012; Seattle, WA
   Google Scholar
• . Brushwood DB, Rich BA, Coleman JJ, Bolen J, Wong W. Legal liability perspectives on abuse-deterrent opioids in the treatment of chronic pain. J Pain Palliat Care Pharmacother. 2010;24(4):333–348
   PubMedGoogle Scholar
• . Cassidy TA, McNaughton EC, Butler SF, Budman SH. Changes in prescription opioid abuse after introduction of an abuse deterrent opioid formulation. Presented at: PAINWeek; September 5–8, 2012; Las Vegas, NV
   Google Scholar
• . Webster LR, Bath B, Medve RA, Marmon T, Stoddard GJ. Randomized, double-blind, placebo-controlled study of the abuse potential of different formulations of oral oxycodone. Pain Med. 2012;13(6):790–801
   PubMed Web of Science ®Google Scholar
• . National Opioid Use Guideline Group (NOUGG). Canadian guideline for safe and effective use of opioids for chronic non-cancer pain. http://nationalpaincentre.mcmaster.ca/opioid/. Accessed May 11, 2010
   Google Scholar