Abuse-deterrent and tamper-resistant opioids: How valuable are novel formulations in thwarting non-medical use?

Expert Opinion on Drug Delivery

Volumn 10, Issue 2, 2013, Pages 229-240

  Lourenço, Laura M ^a   Matthews, Michele ^a,b   Jamison, Robert N ^b  

^a MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Abuse; Abuse deterrent; Addiction; Chronic pain; Misuse; Opioids; Tamper resistant

Indexed keywords

BUPRENORPHINE PLUS NALOXONE; CROSPOVIDONE; DETERX; DODECYL SULFATE SODIUM; EGALET MORPHINE; HYDROCODONE BITARTRATE PLUS PARACETAMOL; HYDROMORPHONE; MACROGOL; MAGNESIUM STEARATE; MICROCRYSTALLINE CELLULOSE; MORPHINE; MORPHINE SULFATE; MORPHINE SULFATE PLUS NALTREXONE; NALOXONE PLUS OXYCODONE; NALOXONE PLUS PENTAZOCINE; NALTREXONE; NALTREXONE PLUS OXYCODONE; NICOTINIC ACID PLUS OXYCODONE; OPIATE; OXYCODONE; OXYMORPHONE; OXYNAL; OXYTREX; PENTAZOCINE; PERCOCET; PLACEBO; POLYMER; POLYSACCHARIDE; PRODRUG; REXISTA; SILICON DIOXIDE; TQ 1015; TRAMADOL; UNCLASSIFIED DRUG;

ABUSE DETERRENT FORMULATION; CHRONIC PAIN; CLINICAL PRACTICE; COLLOID; CONTROLLED RELEASE FORMULATION; DOSAGE SCHEDULE COMPARISON; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG MISUSE; DRUG SURVEILLANCE PROGRAM; DRUG TOLERANCE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE COST; HIGH RISK PATIENT; HUMAN; HYDROGEL; LOW BACK PAIN; MEDICOLEGAL ASPECT; OPIATE ADDICTION; OSTEOARTHRITIS; PAIN; PHARYNX DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); PRESCRIPTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK BENEFIT ANALYSIS; SCREENING; TABLET FORMULATION; TAMPER RESISTANT FORMULATION; UNSPECIFIED SIDE EFFECT; WITHDRAWAL SYNDROME;

ANALGESICS, OPIOID; ANIMALS; CHEMISTRY, PHARMACEUTICAL; CHRONIC PAIN; DRUG COMPOUNDING; DRUG DESIGN; DRUG PRESCRIPTIONS; HUMANS; OPIOID-RELATED DISORDERS; PRESCRIPTION DRUG MISUSE;

EID: 84872733172     PISSN: 17425247     EISSN: 17447593     Source Type: Journal    
DOI: 10.1517/17425247.2013.751095     Document Type: Review

References (65)

1. Frymoyer JW, Cats-Baril WL. An overview of the incidences and costs of low back pain. Orthop Clin North Am 1991;22(2):263-71
2. Institute of Medicine. Relieving Pain in America: a Blueprint for Transforming Prevention, Care, Education, and Research. Consensus report released. 2011. Available from: http://ion. edu/Reports/2011
3. Ehrlich GE. Back pain. J Rheumatol Suppl 2003;67:26-31 (Pubitemid 36961219)
4. Strassels S. Economic burden of prescription opioid misuse and abuse. J Manag Care Pharm 2009;15(7):556-62
5. American Academy of Pain Medicine, American Pain Society. The use of opioids for the treatment of chronic pain: a consensus statement from the American Academy of Pain Medicine and American Pain Society. Clin J Pain 1997;13:6-8
6. Manchikanti L, Helm Ii S, Fellows B, et al. Opioid Epidemic in the United States. Pain Physician 2012;15(3 Suppl):ES9-38
7. 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):683-94
8. Bhamb B, Brown D, Hariharan J, et al. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin 2006;22(9):1859-65 (Pubitemid 44449242)
9. Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med 2006;21(6):652-5 (Pubitemid 43801498)
10. Trescot AM, Boswell MV, Atluri SL, et al. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician 2006;9:1-39
11. Substance Abuse and Mental Health Services Administration. Results from the 2009 National Survey on drug use and health. Volume I Summary of National Findings (Office of Applied Studies, NSDUH Series H-38A, HHS Publication No. SMA 10-4586 Findings); Rockville, MD: 2010
12. Gilson AM, Kreis PG. The burden of the nonmedical use of prescription opioid analgesics. Pain Med 2009;10(Suppl 2):S89-100
13. Mahon WJ. Coalition Against Insurance Fraud. Prescription for peril. How insurance fraud finances theft and abuse of addictive prescription drugs. 2007. Available from: http://www. insurancefraud. org/downloads/drugDiversion. pdf [Accessed 5 August 2012]
14. Webster L, St. Marie B, McCarberg B, et al. Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain. J Opioid Manage 2011;7(3):235-45
15. Yap D. FDA approves final ER/LA opioid analgesic REMS. Pharm Today. 2012. Available from: http://www. pharmacist. com/fda-approvesfinal-erla-opioid- analgesic-rems [Accessed 1 August 2012]
16. Barthwell AG, Barnes MC, Leopold VR, et al. Center for Lawful Access and Abuse Deterrence. National prescription drug abuse prevention strategy. 2009. Available from: http://claad. org/downloads/Nat-Prescript-Drug-Abuse-Prev-Strat- 2009. pdf [Accessed 20 July 2012]
17. National drug control strategy. President of the United States. 2010. Available from: http://www. whitehousedrugpolicy. gov/publications/policy/ ndcs10/ndcs2010. pdf [Accessed 20 July 2012]
18. Jamison RN, Serraillier J, Michna E. Assessment and treatment of abuse risk in opioid prescribing for chronic pain. Pain Res Treat 2011; Article ID 941808, 12 pages Available from: http://www. hindawi. com/journals/prt/2011/ 941808/. [Accessed 10 August 2012]
19. 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 (Pubitemid 43962738)
20. Hays L, Kirsh KL, Passik SD. Seeking drug treatment for Oxycontin abuse: a chart review of consecutive admissions to a substance abuse treatment facility in Kentucky. JNCCN 2003;1(3):423-8
21. Wang HY, Friedman E, Olmstead MC, et al. Ultra-low-dose naloxone suppresses opioid tolerance, dependence and associated changes in mu opioid receptor-G protein coupling and Gbetagamma signaling. Neuroscience 2005;135(1):247-61 (Pubitemid 41219753)
22. Webster LR, Butera PG, Moran LV, et al. Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain 2006;7(12):937-46 (Pubitemid 44854737)
23. Webster L. Update on abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med 2009;10:S124-33
24. Baum C, Hsu JP, Nelson RC. The impact of the addition of naloxone on the use and abuse of pentazocine. Public Health Rep 1987;102(4):426-9 (Pubitemid 17144539)
25. Sunshine A, Axtmayer R, Olson NZ, et al. Analgesic efficacy of pentazocine versus pentazocine-naloxone combination following oral administration. Clin J Pain 1988;3:35-40 (Pubitemid 18096955)
26. 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):303-4
27. Ruan X, Chen T, Gudin J, et al. 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):300-3
28. Katz N, Sun S, Johnson F, et al. 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):303-11
29. Stauffer J, Setnik B, Sokolowska M, et al. 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 nondependent opioid users: a randomized, double-blind, placebo-controlled, crossover study. Clin Drug Investig 2009;29(12):777-90
30. Webster L, Jones JB, Johnson F, et al. Relative drug-liking/euphoria effects of intravenous morphine alone and in combination with naltrexone in recreational opioid users [abstract 2993]. Presented at IASP 12th World Congress on Pain; 17-22 August 2008; Glasgow, Scotland, UK
31. Embeda recall issued due to ongoing manufacturing problems. Available from: http://www. aboutlawsuits. com/embedarecall-manufacturing-problems-16891 [Accessed 3 August 2012]
32. DrugWatch. Pain drug Embeda recalled due to defect in formula. Available from: http://www. reuters. com/article/2011/03/16/pfizer-recall-idUSN16183661 20110316 [Accessed 3 August 2012]
33. Elite Pharmaceuticals I. Elite announces successful results on abuse resistant technology for narcotic analgesics. Business Wire. 2005. Available from: http://findarticles. com/p/articles/mi-m0EIN/is-2005-Dec-8/ai-n15925729/ [Accessed 3 August 2012]
34. OXECTA Full Prescribing Information. King Pharmaceuticals, Inc; Bristol, TN: 2011. Available from: http://labeling. pfizer. com/ShowLabeling. aspx?id=62 [Accessed 3 August 2012].
35. Schneider JP, Matthews ML, Jamison RN. Abuse-deterrent and tamper-resistant opioid formulations: what is their role in addressing prescription opioid abuse? CNS Drugs 2010;24(10):805-10
36. Freeland D, Spivey R, Colucci R. Phase II study of the safety and tolerability of niacin combined with oxycodone HCl 5 mg vs. oxycodone HCl 5 mg alone in healthy adult subjects. Paper presented at: college on Problems of Drug Dependence 71st Annual Meeting; 20-25 June 2009; Reno/Sparks, NV
37. Wood R, Spivey R, Colucci R. Phase II, randomized, double-blind study in fasted and fed healthy subjects to evaluate the dose-response for flushing, tolerability, and safety of escalating doses of niacin. Paper presented at: college on Problems of Drug Dependence 71st Annual Meeting; 20-25 June 2009; Reno/Sparks, NV
38. Daniels SE, Spivey RJ, Singla S, et al. Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. Curr Med Res Opin 2011;27(3):593-603
39. Acura, King get FDA response on Acurox. [news release]. New York: NY; Wall Street Journal (Market Watch). 2009. Available from: http://articles. marketwatch. com/2009-07-02/news/30950424-1-complete-response-letterking- pharmaceuticals-fda-response [Accessed 12 July 2012]
40. FDA approves new formulation for OxyContin [news release]. Silver Spring, MD; US Department of Health and Human Services. US Food and Drug Administration. 2010. Available from: http://www. fda. gov/NewsEvents/Newsroom/ PressAnnouncements/ucm207480. htm [Accessed 1 August 2012]
41. Cicero TJ, Ellis MS, Surratt HC. Effect of abuse-deterrent formulation of Oxycontin. N Engl J Med 2012;367:187-9
42. Butler SF, Cassidy TA, Chilcoat H, et al. Abuse rates and routes of administration of reformatted Oxycontin: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain 2012; In press
43. Galia E, Schwier S, Lehrach I, et al. Oxymorphone extended release tablets with improved tamper resistant properties. Paper presented at: American Pain Society 31st Annual Scientific Meeting; 16-19 May 2012; Honolulu, HI
44. Benedek IH, Jobes J, Xiang Q, Fiske WD. Bioequivalence of oxymorphone extended release and crush-resistant oxymorphone extended release. Drugs Des Devel Ther 2011;5:455-63
45. Fiske WD, Jobes J, Xiang Q, et al. The effects of ethanol on the bioavailability of oxymorphone extended-release tablets and oxymorphone crush-resistant extended-release tablets. J Pain 2012;13(1):90-9
46. Schoedel KA, McMorn S, Chakraborty B, et al. Positive and negative subjective effects of extended-release oxymorphone versus controlled-release oxycodone in recreational opioid users. J Opioid Manag 2011;7(3):179-92
47. Vallejo R, Bark RL, Wang VC. Pharmacology of opioids in the treatment of chronic pain syndromes. Pain Physician 2011;14(4):E343-60
48. Butler S, Black R, Cassidy T, et al. Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J. 2011. 8: 29. Published online 2011 October 19 Available from: http://www. harmreductionjournal. com/content/8/1/29
49. IntelliPharmaCeutics Ltd. IntelliPharmaCeutics announces successful completion of a pilot clinical trial for its abuse and alcohol resistant sustained release oxycodone. 2008. Available from: http://www. intellipharmaceutics. net [Accessed 3 August 2012]
50. Fleming AB, Noonan PK, Schiller M, et al. Tamper-resistant properties of a novel, multiparticulate, extended-release formulation of oxycodone for the treatment of moderate to severe pain. Paper presented at: american Academy of Pain Medicine 26th Annual Meeting; 3-6 February 2010; San Antonio, TX
51. Collegium Pharmaceuticals, Inc. Collegium Pharmaceuticals, Inc., announces U. S. patent issued covering its DETERx abuse deterrent sustained release technology. 2008. Available from: http://www. collegiumpharma. com/news/20080716. html [Accessed 3 August 2012]
52. Ridgway D, Sopata M, Burneckis A, et al. Clinical efficacy and safety of once-daily dosing of a novel, prolonged-release oral morphine tablet compared with twice-daily dosing of a standard controlled-release morphine tablet in patients with cancer pain: a randomized, double-blind, exploratory crossover study. J Pain Symptom Manage 2010;39(4):712-20
53. Brennan MJ, Stanos S. Strategies to optimize pain management with opioids while minimizing risk of abuse. PMR 2010;2(6):544-58
54. Akela Pharma initiates its first abuse deterrent opioid phase I clinical trial [news release]. Montreal, Canada' Akela Pharma. 2008. Available from: http://www. akelapharma. com/modules. php?op=modload&name=News& file=article&sid=67 [Accessed 1 August 2012]
55. Palladone for chronic pain. Med Lett Drugs Ther 2005;47:21-3
56. Sathyan G, Sivakumar K, Thipphawond J. Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol. Curr Med Res Opin 2008;24(1):297-305 (Pubitemid 351160261)
57. Hale A, 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;26:1505-18
58. de Kater A, Butera P, Haux JE, et al. Alcohol does not compromise abuse-resistant CR oxycodone. Paper presented at: american Academy of Pain Medicine 24th Annual Meeting; 12-16 February 2008; Orlando, FL
59. Butler SF, Black R, Grimes-Serrano JM, et al. Estimating attractiveness for abuse of a not-yet-marketed "abuse-deterrent" prescription opioid formulation. Pain Med 2010;11(1):81-91
60. Merrigan T, Friedmann N, Butera P, et al. Abuse-resistant, controlled-release oxycodone treats chronic pain. Paper presented at: american Academy of Pain Medicine 24th Annual Meeting; 12-16 February 2008; Orlando FL
61. FDA complete response letter received for Remoxy [news release]. New York: NY; Pfizer and Pain Therapeutics, Inc. 2011. Available from: http://www. pfizer. com/news/press-releases/pfizer-press-release. jsp?guid= 20110624005389en& source=RSS-2011&page=11 [Accessed 12 July 2012]
62. Guidance for industry: assessment of abuse potential of drugs. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) US Department of Health & Human Services; Rockville MD; 2010.
63. McCabe SE, Cranford JA, Boyd CJ, Teter CJ. Motives, diversion and routes of administration associated with nonmedical use of prescription opioids. Addict Behav 2007;32:562-75 (Pubitemid 46038570)
64. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain 2007;130:144-56 (Pubitemid 46843461)
65. Butler SF, Budman SH, Fernandez K, et al. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain 2008;9:360-72