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PAIN MANAGEMENT, PALLIATIVE CARE, AND SUBSTANCE ABUSE

Assessment of Extended-Release Opioid Analgesics for the Treatment of Chronic Pain

Pages 49-61 | Received 05 Dec 2012, Accepted 12 Dec 2012, Published online: 25 Mar 2013

REFERENCES

  • US Census Bureau. Preliminary annual estimates of the resident population for the United States, regions, states, and Puerto Rico: April 1, 2000 to July 1, 2010 (NST-PEST2010–01). 2002 estimates. Available at: http://www. census.gov/popest/research/eval-estimates/NST-PEST2010–01.xls. Accessed May 8, 2012.
  • National Center for Health Statistics. Health, United States, 2006. With Chartbook on Trends in the Health of Americans. Hyattsville, MD: National Center for Health Statistics; 2006.
  • Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011.
  • Narayana A, Brook RA. A healthcare claims database analysis to estimate the prevalence of chronic opioid use in adult patients in the United States. Presented at the 25th Annual Meeting of the American Academy of Pain Medicine; January 28–31, 2009; Honolulu, HI. Pain Med. 2009;10(1): abstract 278.
  • Chou R, Fanciullo GJ, Fine PG, Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10:113–130.
  • Chou R, Qaseem A, Snow V, 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.
  • Pergolizzi J, Boger RH, Budd K, Opioids and the management of chronic severe pain in the elderly: consensus statement of an International Expert Panel with focus on the six clinically most often used World Health Organization Step III opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone). Pain Pract. 2008;8:287–313.
  • Adams MP, Ahdieh H. Pharmacokinetics and dose-proportionality of oxymorphone extended release and its metabolites: results of a randomized crossover study. Pharmacotherapy. 2004;24:468–476.
  • Portenoy RK, Sciberras A, Eliot L, Loewen G, Butler J, Devane J. Steady-state pharmacokinetic comparison of a new, extended-release, once-daily morphine formulation, Avinza, and a twice-daily controlled-release morphine formulation in patients with chronic moderate-to-severe pain. J Pain Symptom Manage. 2002;23:292–300.
  • Adler L, McDonald C, O'Brien C, Wilson M. A comparison of once-daily tramadol with normal release tramadol in the treatment of pain in osteoarthritis. J Rheumatol. 2002;29:2196–2199.
  • Hagen NA, Thirlwell M, Eisenhoffer J, Quigley P, Harsanyi Z, Darke A. Efficacy, safety, and steady-state pharmacokinetics of once-a-day controlled-release morphine (MS Contin XL) in cancer pain. J Pain Symptom Manage. 2005;29: 80–90.
  • Moore KT, St-Fleur D, Marricco NC, Steady-state pharmacokinetics of extended-release hydromorphone (OROS hydromorphone): a randomized study in healthy volunteers. J Opioid Manag. 2010;6:351–358.
  • McCarberg BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther. 2001;8: 181–186.
  • Rauck RL. What is the case for prescribing long-acting opioids over short-acting opioids for patients with chronic pain? A critical review. Pain Pract. 2009;9:468–479.
  • Caldwell JR. Avinza—24-h sustained-release oral morphine therapy. Expert Opin Pharmacother. 2004;5:469–472.
  • Mystakidou K, Clark AJ, Fischer J, Lam A, Pappert K, Richarz U. Treatment of chronic pain by long-acting opioids and the effects on sleep. Pain Pract. 2011;11:282–289.
  • Brennan MJ, Lieberman JA 3rd. Sleep disturbances in patients with chronic pain: effectively managing opioid analgesia to improve outcomes. Curr Med Res Opin. 2009;25:1045–1055.
  • Fine PG, Mahajan G, McPherson ML. Long-acting opioids and short-acting opioids: appropriate use in chronic pain management. Pain Med. 2009;10(Suppl 2):S79–S88.
  • Gourlay DL, Heit HA. Universal precautions revisited: managing the inherited pain patient. Pain Med. 2009;10(Suppl 2):S115–S123.
  • Pergolizzi JV, Taylor R, Raffa RB. Extended-release formulations of tramadol in the treatment of chronic pain. Expert Opin Pharmacother. 2011;12:1757–1768.
  • Sathyan G, Xu E, Thipphawong J, Gupta SK. Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence and absence of food. BMC Clin Pharmacol. 2007;7:2.
  • Sathyan G, Sivakumar K, Thipphawong J. Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol. Curr Med Res Opin. 2008;24:297–305.
  • Smith H, Bruckenthal P. Implications of opioid analgesia for medically complicated patients. Drugs Aging. 2010;27: 417–433.
  • Smith HS. Opioid metabolism. Mayo Clin Proc. 2009; 84:613–624.
  • Duragesic (fentanyl transdermal system) [package insert]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.; 2009.
  • OxyContin (oxycodone hydrochloride controlled-release) tablets CII [package insert]. Stamford, CT: Purdue Pharma L.P.; 2011.
  • Ultram ER (tramadol hydrochloride) [package insert]. Raritan, NJ: Ortho-McNeil; 2009.
  • Vicodin (hydrocodone bitartrate and acetaminophen tablets). North Chicago, IL: Abbott Laboratories; 2011.
  • Methadone hydrochloride tablets [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; 2009.
  • Exalgo (hydromorphone HCl) extended-release tablets, CII [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; 2012.
  • Opana ER (oxymorphone hydrochloride) extended-release tablets [package insert]. Chadds Ford, PA: Endo Pharmaceuticals, Inc.; 2012.
  • Avinza (morphine sulfate extended-release capsules) [package insert]. Bristol, TN: King Pharmaceuticals, Inc.; 2008.
  • Parsells Kelly J, Cook SF, Kaufman DW, Anderson T, Rosenberg L, Mitchell AA. Prevalence and characteristics of opioid use in the US adult population. Pain. 2008;138: 507–513.
  • Governale L. Outpatient prescription opioid utilization in the US, year 2000–2009. US Food and Drug Administration. 2010. Available at: http://www.fda.gov/downloads/Advisory Committess/CommittessMeetingMaterials/Drugs/DrugSafety andRiskManagementAdvisoryCommittee/UCM220950.pdf. Accessed May 27, 2011.
  • Joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. July 22–23, 2010; Adelphi, MD.
  • US Department of Health and Human Services, Centers for Disease Control and Prevention, Office of Public Preparedness and Response. Opioid analgesics: the epidemiology of misuse and advice on prescribing. August 17, 2010. Available at: http://emergency.cdc.gov/coca/ppt/08_17_10_Opioid_FINAL. pdf. Accessed May 11, 2012.
  • Katz NP, Adams EH, Chilcoat H, Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007;23:648–660.
  • McCarberg BH. Pain management in primary care: strategies to mitigate opioid misuse, abuse, and diversion. Postgrad Med. 2011;123:119–130.
  • Haanpaa ML, Backonja MM, Bennett MI, Assessment of neuropathic pain in primary care. Am J Med. 2009;122:S13–S21.
  • Khouzam RH. Chronic pain and its management in primary care. South Med J. 2000;93:946–952; quiz 953.
  • McCarberg BH, Adler JA. Updates on managing acute and chronic pain in primary care practice—optimizing pain reduction, minimizing adverse events. JAAPA. 2008;(Suppl Pain):1–13.
  • Gagnon AM, Kahan M, Srivastava A. Opioid use and abuse: is there a problem? Clin J Pain. 2007;23:661–662.
  • Touchet BK, Yates WR, Coon KA. Opioid contract use is associated with physician training level and practice specialty. J Opioid Manag. 2005;1:195–200.
  • Drug Abuse Warning Network. Selected Tables: National Estimates, Drug-Related Emergency Department Visits for 2004–09. Available at: https://dawninfo.samhsa.gov/data/ default.asp?met=All. Accessed April 26, 2011.
  • US Department of Health and Human Services, Centers for Disease Control and Prevention. Unintentional drug poisoning in the United States. July 2010. Available at: http:// www.cdc.gov/HomeandRecreationalSafety/pdf/poision-issue-brief.pdf. Accessed May 11, 2012.
  • Walsh SL, Nuzzo PA, Lofwall MR, Holtman JR Jr. The relative abuse liability of oral oxycodone, hydrocodone and hydromorphone assessed in prescription opioid abusers. Drug Alcohol Depend. 2008;98:191–202.
  • Marsch LA, Bickel WK, Badger GJ, Effects of infusion rate of intravenously administered morphine on physiological, psychomotor, and self-reported measures in humans. J Pharmacol Exp Ther. 2001;299:1056–1065.
  • Comer SD, Ashworth JB, Sullivan MA, Vosburg SK, Saccone PA, Foltin RW. Relationship between rate of infusion and reinforcing strength of oxycodone in humans. J Opioid Manag. 2009;5:203–212.
  • Webster LR, Bath B, Medve RA. Opioid formulations in development designed to curtail abuse: who is the target? Expert Opin Investig Drugs. 2009;18:255–263.
  • Setnik B, Roland CL, Cleveland JM, Webster L. The abuse potential of remoxy®, an extended-release formulation of oxycodone, compared with immediate- and extended-release oxycodone. Pain Med. 2011;12:618–631.
  • Shram MJ, Sathyan G, Khanna S, Evaluation of the abuse potential of extended release hydromorphone versus immediate release hydromorphone. J Clin Psychopharmacol. 2010;30:25–33.
  • Katz N, Fernandez K, Chang A, Benoit C, Butler SF. Internet-based survey of nonmedical prescription opioid use in the United States. Clin J Pain. 2008;24:528–535.
  • 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;20:5–13.
  • Katz N. Abuse-deterrent opioid formulations: are they a pipe dream? Curr Rheumatol Rep. 2008;10:11–18.
  • Embeda (morphine sulfate and naltrexone hydrochloride) [package insert]. Bristol, TN: King Pharmaceuticals; 2012.
  • Kadian (morphine sulfate extended-release) capsules [package insert]. Morristown, NJ: Actavis Elizabeth LLC; 2012.
  • MS Contin (morphine sulfate controlled-release) tablets [package insert]. Stamford, CT: Purdue Pharma L.P.; 2009.
  • Oramorph SR (morphine sulfate) sustained release tablets [package insert]. Newport, KY: Xanodyne Pharmaceticals, Inc.; 2006.
  • Butrans (buprenorphine) transdermal system for transdermal administration [prescribing information]. Stamford, CT: Purdue Pharma L.P.; 2010.
  • Nucynta ER (tapentadol) extended-release oral tablets [package insert]. Titusville, NJ: Janssen Pharmaceuticals; 2011.
  • Fentanyl transdermal system [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; 2009.
  • Hale M, Khan A, Kutch M, Li S. 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.
  • Turgeon J, Groning R, Sathyan G, Thipphawong J, Richarz U. The pharmacokinetics of a long-acting OROS hydromorphone formulation. Expert Opin Drug Deliv. 2010;7:137–144.
  • Gupta S, Sathyan G. Providing constant analgesia with OROS hydromorphone. J Pain Symptom Manage. 2007;33(2 Suppl):S19–S24.
  • Angst MS, Drover DR, Lotsch J, Pharmacodynamics of orally administered sustained- release hydromorphone in humans. Anesthesiology. 2001;94:63–73.
  • Richarz U, Vandenbossche J, Moore K. Characterization of the steady-state pharmacokinetic profile of once-daily hydromorphone ER (OROS hydromorphone) versus IR hydromorphone in healthy volunteers [abstract]. J Pain. 2011;12(4 Suppl): P60.
  • Pande P, Hines J, Brogan A. Tamper-resistant properties of once-daily hydromorphone ER (OROS hydromorphone) [abstract]. J Pain. 2011;12(4 Suppl):P58.
  • OxyContin (oxycodone hydrochloride controlled-release) tablets CII [package insert]. Stamford, CT: Purdue Pharma L.P.; 2010. [Old formulation; no longer available].
  • Jayawant SS, Balkrishnan R. The controversy surrounding OxyContin abuse: issues and solutions. Ther Clin Risk Manag. 2005;1:77–82.
  • US Department of Health and Human Services, US Food and Drug Administration. FDA approves new formulation for OxyContin [news release]; April 5, 2010. Available at: http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm207480.htm. Updated April 7, 2010. Accessed April 17, 2012.
  • Horn JR, Hansten PD. Get to know an enzyme: CYP3A4. Pharmacy Times. 2008. Published online September 1, 2008. http://pharmacytimes.com/publications/issue/2008/2008-09-8687. Accessed February 11, 2013.
  • Webster LR, Fine PG. Approaches to improve pain relief while minimizing opioid abuse liability. J Pain. 2010;11:602–611.
  • Black R, Coplan P, Cassidy T, Effects of reformulated OxyContin® among patients assessed for substance abuse treatment in the NAVIPPRO sentinel surveillance network [abstract]. J Pain. 2012;13(4 Suppl):S58.
  • Benedek IH, Jobes J, Xiang Q, Fiske WD. Bioequivalence of oxymorphone extended release and crush-resistant oxymorphone extended release. Drug Des Dev Ther. 2011;5:455–463.
  • Bartholomaeus JH, Arkenau-Marić E, Galia E. Opioid extended-release tablets with improved tamper-resistant properties. Expert Opin Drug Deliv. 2012;9:879–891.
  • Fiske WD, Jobes J, Xiang Q, Chang S-C, Benedek IH. The effects of ethanol on the bioavailability of oxymorphone extended-release tablets and oxymorphone crush-resistant extended-release tablets. J Pain. 2012;13:90–99.
  • Miller DA, Dinunzio JC, Williams RO 3rd. Advanced formulation design: improving drug therapies for the management of severe and chronic pain. Drug Dev Ind Pharm. 2008;34:117–133.
  • Johnson FK, Ciric S, Boudriau S, Kisicki JC, Stauffer J. The relative bioavailability of morphine sulfate and naltrexone hydrochloride extended release capsules (EMBEDA) and an extended release morphine sulfate capsule formulation (KADIAN) in healthy adults under fasting conditions. Am J Ther. 2011;18:2–8.
  • 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;11:303–311.
  • Johnson F, Wagner G, Sun S, Stauffer J. Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules. J Pain. 2008;9:330–336.
  • Raffa RB, Pergolizzi JV Jr. Opioid formulations designed to resist/deter abuse. Drugs. 2010;70:1657–1675.
  • 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 Invest. 2009;29:777–790.
  • 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;6:300–303.
  • Plosker GL. Buprenorphine 5, 10 and 20 μ/h transdermal patch: a review of its use in the management of chronic non-malignant pain. Drugs. 2011;71:2491–2509.
  • Yokell MA, Zaller ND, Green TC, Rich JD. Buprenorphine and buprenorphine/naloxone diversion, misuse, and illicit use: an international review. Curr Drug Abuse Rev. 2011;4:28–41.
  • Nelson L, Schwaner R. Transdermal fentanyl: pharmacology and toxicology. J Med Toxicol. 2009;5:230–241.
  • Kuhlman JJ, McCaulley R, Valouch TJ, Fentanyl use, misuse, and abuse: a summary of 23 postmortem cases. J Anal Toxicol. 2003;27:499–504.
  • Lilleng PK, Mehlum LI, Bachs L, Deaths after intravenous misuse of transdermal fentanyl. J Forensic Sci. 2004;49:1–3.
  • Reeves MD, Ginifer CJ. Fatal intravenous misuse of transdermal fentanyl. Med J Aust. 2002;177:552–553.
  • Marier J-F, Lor M, Potvin D, DiMarco M, Morelli G, Sædder EA. Pharmacokinetics, tolerability, and performance of a novel matrix transdermal delivery system of fentanyl relative to the commercially available reservoir formulation in healthy subjects. J Clin Pharmacol. 2006;46: 642–653.
  • Sellers EM, Schuller R, Romach MK, Relative abuse potential of opioid formulations in Canada: a structured field study. J Opioid Manag. 2006;2:219–227.
  • Prosser JM, Jones BE, Nelson L. Complications of oral exposure to fentanyl transdermal delivery system patches. J Med Toxicol. 2010;6:443–447.
  • Freynhagen R, von Giesen HJ, Busche P, Sabatowski R, Konrad C, Grond S. Switching from reservoir to matrix systems for the transdermal delivery of fentanyl: a prospective, multicenter pilot study in outpatients with chronic pain. J Pain Symptom Manage. 2005;30:289–297.
  • Sathyan G, Guo C, Sivakumar K, Gidwano S, Gupta S. Evaluation of the bioequivalence of two transdermal fentanyl systems following single and repeat applications. Curr Med Res Opin. 2005;21:1961–1968.
  • US Department of Health and Human Services, US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids. Available at: http://www.fda.gov/drugs/drugsafety/ informationbydrugclass/ucm163647.htm. Updated July 16, 2012. Accessed July 26, 2012.
  • Craig DS. The Food and Drug Administration risk evaluation and mitigation strategy. J Pain Palliat Care Pharmacother. 2010;24:145–148.
  • US Department of Health and Human Services, US Food and Drug Administration. Questions and answers: FDA approves a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. Available at: http://www.fda.gov/Drugs/DrugSafety/Information byDrugClass/ucm309742.htm. Updated July 14, 2012. Accessed July 26, 2012.
  • US Department of Health and Human Services, US Food and Drug Administration. FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. Available at: http://www.fda.gov/downloads/Drugs/ DrugSafety/InformationbyDrugClass/ucm277916.pdf. Updated July 9, 2012. Accessed July 26, 2012.
  • Medical Board of California. New laws related to continuing medical education. Available at: http://www.mbc.ca.gov/ licensee/continuing_education_laws.html. Accessed May 10, 2012.
  • US Department of Health and Human Services, US Food and Drug Administration. Post-approval REMS notification. 2011. Available at: http://www.fda.gov/downloads/Drugs/ DrugSafety/InformationByDrugClass/UCM251595.pdf. Accessed May 10, 2012.

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