Assessment of a formulation designed to be crush-resistant in prescription opioid abusers

Drug and Alcohol Dependence

Volumn 126, Issue 1-2, 2012, Pages 206-215

  Vosburg, Suzanne K ^a   Jones, Jermaine D ^a   Manubay, Jeanne M ^a   Ashworth, Judy B ^b   Benedek, Irma H ^c   Comer, Sandra D ^a  

^a NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

^b GRÜNENTHAL GMBH   (Germany)

^c Formerly with Endo Pharmaceuticals   (United States)

Author keywords

Abuse deterrent; Laboratory model; Oxymorphone; Prescription opioid; Tamper resistant

Indexed keywords

OXYMORPHONE; TIMERX; UNCLASSIFIED DRUG;

ADULT; ANALGESIC AGENT ABUSE; ARTICLE; COMPARATIVE STUDY; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; CRUSH RESISTANT DRUG FORMULATION; DRUG ABUSE; DRUG DESIGN; DRUG FORMULATION; DRUG ISOLATION; FEMALE; HIGH RISK BEHAVIOR; HUMAN; INTRANASAL DRUG ABUSE; INTRAVENOUS DRUG ABUSE; MALE; OUTCOME ASSESSMENT; PARTICLE SIZE; PRESCRIPTION; PRIORITY JOURNAL; RANDOM SAMPLE; RISK REDUCTION;

ADMINISTRATION, INTRANASAL; ADULT; ANALGESICS, OPIOID; CHEMISTRY, PHARMACEUTICAL; DATA INTERPRETATION, STATISTICAL; DELAYED-ACTION PREPARATIONS; DEMOGRAPHY; EXCIPIENTS; FEMALE; HARDNESS TESTS; HUMANS; HYDROGELS; MALE; MIDDLE AGED; OPIOID-RELATED DISORDERS; OXYMORPHONE; PARTICLE SIZE; POLYSACCHARIDES; POWDERS; SUBSTANCE ABUSE, INTRAVENOUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84867881321     PISSN: 03768716     EISSN: 18790046     Source Type: Journal    
DOI: 10.1016/j.drugalcdep.2012.05.013     Document Type: Article

References (74)

1. Abreu M.E., Bigelow G.E., Fleisher L., Walsh S.L. Effect of intravenous injection speed on responses to cocaine and hydromorphone in humans. Psychopharmacology 2001, 154:76-84.
2. Adiseshiah M., Jones D.A., Round J.M. Intra-arterial temazepam. BMJ 1992, 304:1630.
3. Bhabra M.S., Meshikhes A.N., Thomson G.J., Craig P., Parrott N.R. Intraarterial temazepam: an important cause of limb ischaemia in intravenous drug abusers. Eur. J. Vasc. Surg. 1994, 8:240-242.
4. Birnbaum H.G., White A.G., Reynolds J.L., Greenberg P.E., Zhang M., Vallow S., Schein J.R., Katz N.P. Estimated costs of prescription opioid analgesic abuse in the United States in 2001: a societal perspective. Clin. J. Pain 2006, 22:667-676.
5. Birnbaum H.G., White A.G., Schiller M., Waldman T., Cleveland J.M., Roland C.L. Societal costs of prescription opioid abuse, dependence, and misuse in the united states. Pain Med. 2011, 12:657-667.
6. Blair S.D., Holcombe C., Coombes E.N., O'malley M.K. Leg ischaemia secondary to non-medical injection of temazepam. Lancet 1991, 338:1393-1394.
7. Budman S.H., Grimes Serrano J.M., Butler S.F. Can abuse deterrent formulations make a difference?. Expectation and speculation. Harm Reduct. J. 2009, 6:8-15.
8. Butler S.F., Benoit C., Budman S.H., Fernandez K.C., Mccormick C., Venuti S.W., Katz N. Development and validation of an opioid attractiveness scale: a novel measure of the attractiveness of opioid products to potential abusers. Harm Reduct. J. 2006, 3:5-16.
9. Butler S.F., Black R.A., Cassidy T.A., Dailey T.M., Budman S.H. Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct. J. 2011, 8:29-38.
10. Butler S.F., Black R., Grimes Serrano J.M., Folensbee L., Chang A., Katz N. Estimating attractiveness for abuse of a not-yet-marketed " abuse-deterrent" prescription opioid formulation. Pain Med. 2010, 11:81-91.
11. Butler S.F., Fernandez K.C., Chang A., Benoit C., Morey L.C., Black R., Katz N. Measuring attractiveness for abuse of prescription opioids. Pain Med. 2010, 11:67-80.
12. Carnwath T. Temazepam tablets as drugs of misuse. BMJ 1993, 307:385-386.
13. Coleman J.J., Bensinger P.B., Gold M.S., Smith D.E., Bianchi R.P., Dupont R.L. Can drug design inhibit abuse?. J. Psychoactive Drugs 2005, 37:343-362.
14. Coleman J.J., Schuster C.R., Dupont R.L. Reducing the abuse potential of controlled substances. Pharm. Med. 2010, 24:21-36.
15. Comer S.D., Ashworth J.B., Sullivan M.A., Vosburg S.K., Saccone P.A., Foltin R.W. Relationship between rate of infusion and reinforcing strength of oxycodone in humans. J. Opioid Manage. 2009, 5:203-212.
16. Cone E.J. Ephemeral profiles of prescription drug and formulation tampering: evolving pseudoscience on the internet. Drug Alcohol Depend. 2006, 83:S31-S39.
17. Crompton B. Misuse of benzodiazepines. Voluntary ban on prescribing is effective. BMJ 1994, 308:1709.
18. De Wit H., Bodker B., Ambre J. Rate of iOXMease of plasma drug level influences subjective response in humans. Psychopharmacology 1992, 107:352-358.
19. De Wit H., Dudish S., Ambre J. Subjective and behavioral effects of diazepam depend on its rate of onset. Psychopharmacology 1993, 112:324-330.
20. Dobbin M., Martyres R.F., Clode D., Champion De Crespigny F.E. Association of benzodiazepine injection with the prescription of temazepam capsules. Drug Alcohol Rev. 2003, 22:153-157.
21. Drake J., Ballard R. Reply from the manufacturer. BMJ 1988, 297:1402.
22. Farré M., Camí J. Pharmacokinetic considerations in abuse liability evaluation. Br. J. Addict. 1991, 86:1601-1606.
23. Farrell M., Strang J. Misuse of temazepam. BMJ 1988, 297:1402.
24. Fox R., Beeching N.J., Morrison C., Ruben S., Garvey T. Misuse of temazepam. BMJ 1992, 305:253.
25. Friedmann N., Klutzaritz V., Webster L. Long-term safety of remoxy(r) (extended-release oxycodone) in patients with moderate to severe chronic osteoarthritis or low back pain. Pain Med. 2011, 12:755-760.
26. Friedmann N., Klutzaritz V., Webster L. Efficacy and safety of an extended-release oxycodone (remoxy) formulation in patients with moderate to severe osteoarthritic pain. J. Opioid Manage. 2011, 7:193-202.
27. Garside D., Hargrove R.L., Winecker R.E. Concentration of oxymorphone in postmortem fluids and tissue. J. Anal. Toxicol. 2009, 33:121-128.
28. Green T.C., Black R., Grimes Serrano J.M., Budman S.H., Butler S.F. Typologies of prescription opioid use in a large sample of adults assessed for substance abuse treatment. PLoS One 2011, 6:e27244.
29. Hamed E., Moe D. Development of tamper deterrent formulations: state of the pharmaceutical industry. Curr. Drug Abuse Rev. 2010, 3:139-146.
30. Hansen R.N., Oster G., Edelsberg J., Woody G.E., Sullivan S.D. Economic costs of nonmedical use of prescription opioids. Clin. J. Pain 2011, 27:194-202.
31. Hays L.R. A profile of oxycontin addiction. J. Addict. Dis. 2004, 23:1-9.
32. Johnson F., Setnik B. Morphine sulfate and naltrexone hydrochloride extended-release capsules: naltrexone release, pharmacodynamics, and tolerability. Pain Physician 2011, 14:391-406.
33. Johnson R.E., Strain E.C., Amass L. Buprenorphine: how to use it right. Drug Alcohol Depend. 2003, 70:S59-S77.
34. Jones J.D., Vosburg S.K., Manubay J.M., Comer S.D. Oxycodone abuse in New York City: characteristics of intravenous and intranasal users. Am. J. Addict. 2011, 20:190-195.
35. Katz N. Abuse-deterrant opioid formulations: are they a pipe dream?. Curr. Rheumatol. Rep. 2008, 10:11-18.
36. Katz N., Dart R.C., Bailey E., Trudeau J., Osgood E., Paillard F. Tampering with prescription opioids: nature and extent of the problem, health consequences, and solutions. Am. J. Drug Alcohol Abuse 2011, 37:205-217.
37. Katz N., Fernandez K., Chang A., Benoit C., Butler S.F. Internet-based survey of nonmedical prescription opioid use in the united states. Clin. J. Pain 2008, 24:528-535.
38. Katz N.P., Buse D.C., Budman S.H., Wing Venuti S., Fernandez K.C., Benoit C., Bianchi R., Cooper D., Jasinski D.R., Smith D.E., Butler S.F. Development and preliminary experience with an ease of extractability rating system for prescription opioids. Drug Dev. Ind. Pharm. 2006, 32:727-746.
39. Launchbury A.P., Drake J., Seager H. Misuse of temazepam. BMJ 1992, 305:252-253.
40. Launchbury A.P., Morton F.S.S., Lacy J.E. The development of temazepam gelthix. Manuf. Chem. 1989, 60:38-40.
41. Macias J., Palacios R.B., Claro E., Vargas J., Vergara S., Mira J.A., Merchante N., Corzo J.E., Pineda J.A. High prevalence of hepatitis c virus infection among noninjecting drug users: association with sharing the inhalation implements of crack. Liver Int. 2008, 28:781-786.
42. Mannion R. New formulation OxyContin® tablets: development and properties. Presentation to the Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee 2008.
43. Marsch L.A., Bickel W.K., Badger G.J., Rathmell J.P., Swedberg M.D., Jonzon B., Norsten-Hoog C. 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.
44. Martinez A., Talal A.H. Noninjection drug use: an under-appreciated risk factor for hepatitis c virus transmission. Liver Int. 2008, 28:757-760.
45. Maxwell J.C. The prescription drug epidemic in the united states: a perfect storm. Drug Alcohol Rev. 2011, 30:264-270.
46. McIntyre I.M., Sherrard J.L., Nelson C.L. Case report: oxymorphone-involved fatalities: a report of two cases. J. Anal. Toxicol. 2009, 33:615-619.
47. Mendelson J., Jones R.T. Clinical and pharmacological evaluation of buprenorphine and naloxone combinations: why the 4:1 ratio for treatment?. Drug Alcohol Depend. 2003, 70:S29-S37.
48. Moley F.M., Dawkes M., Berry J.P. Misuse of benzodiazepines. Avoid benzodiazepines whenever possible. BMJ 1994, 308:1709-1710.
49. Mumford G.K., Evans S.M., Fleishaker J.C., Griffiths R.R. Alprazolam absorption kinetics affects abuse liability. Clin. Pharmacol. Ther. 1995, 57:356-365.
50. Nelson R.A., Boyd S.J., Ziegelstein R.C., Herning R., Cadet J.L., Henningfield J.E., Schuster C.R., Contoreggi C., Gorelick D.A. Effect of rate of administration on subjective and physiological effects of intravenous cocaine in humans. Drug Alcohol Depend. 2006, 82:19-24.
51. Oldendorf W.H. Some relationships between addiction and drug delivery to the brain. NIDA Res. Monogr. 1992, 120:13-25.
52. Raffa R.B., Pergolizzi J.V. Opioid formulations designed to resist/deter abuse. Drugs 2010, 70:1657-1675.
53. Roset P.N., Farre M., De La Torre R., Mas M., Menoyo E., Hernandez C., Cami J. Modulation of rate of onset and intensity of drug effects reduces abuse potential in healthy males. Drug Alcohol Depend. 2001, 64:285-298.
54. Ruben S.M., Morrison C.L. Temazepam misuse in a group of injecting drug users. Br. J. Addict. 1992, 87:1387-1392.
55. Russell I.D., Kane G.G., Royle C.A., Jackson D.S. Aggressive management of intra-arterial temazepam injection. J. R. Army Med. Corps 1994, 140:93-94.
56. Scheinmann R., Hagan H., Lelutiu-Weinberger C., Stern R., Des Jarlais D.C., Flom P.L., Strauss S. Non-injection drug use and hepatitis c virus: a systematic review. Drug Alcohol Depend. 2007, 89:1-12.
57. Scott R.N., Going J., Woodburn K.R., Gilmour D.G., Reid D.B., Leiberman D.P., Maraj B., Pollock J.G. Intra-arterial temazepam. BMJ 1992, 304:1630.
58. Setnik B., Roland C.L., Cleveland J.M., Webster L. The abuse potential of remoxy((r)), an extended-release formulation of oxycodone, compared with immediate- and extended-release oxycodone. Pain Med. 2011, 12:618-631.
59. Shaw M., Brabbins C., Ruben S. Misuse of benzodiazepines. Specify the formulation when prescribing. BMJ 1994, 308:1709.
60. Smith H.S. Morphine sulfate and naltrexone hydrochloride extended release capsules for the management of chronic, moderate-to-severe pain, while reducing morphine-induced subjective effects upon tampering by crushing. Expert Opin. Pharmacother. 2011, 12:1111-1125.
61. Strain E.C., Harrison J.A., Bigelow G.E. Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble films. Clin. Pharmacol. Ther. 2011, 89:443-449.
62. Strang J., Griffiths P., Abbey J., Gossop M. Survey of use of injected benzodiazepines among drug users in Britain. BMJ 1994, 308:1082.
63. Strassels S.A. Economic burden of prescription opioid misuse and abuse. J. Manage. Care Pharm. 2009, 15:556-562.
64. Substance Abuse and Mental Health Services Administration, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Substance Abuse and Mental Health Services Administration, Rockville, MD, 2011.
65. Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Treatment Episode Data Set (TEDS) Highlights - 2007 National Admissions to Substance Abuse Treatment Services. OAS Series #S-45, HHS Publication No. (SMA) 09-4360, Rockville, MD, 2009.
66. Surratt H., Kurtz S.P., Cicero T.J. Alternate routes of administration and risk for hiv among prescription opioid abusers. J. Addict. Dis. 2011, 30:334-341.
67. Tzschentke T.M., Cristoph T., Kögel B., Schiene K., Hennies H.-H., Englberger W., Haurand M., Jahnel U., Cremers T.I.F.H., Friderichs E., de Vry J. (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (Tapentadol HCl): a novel μ-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J. Pharmacol. Exp. Ther. 2007, 323:265-276.
68. Tzschentke T.M., Jahnel U., Kögel B., Cristoph T., Englberger W., de Vry J., Schiene K., Okamoto A., Upmalis D., Weber J., Lange C., Stegmann J.-U., Kleinert R. Tapentadol hydrochloride: a next-generation, centrally active analgesic with two mechanisms of action in a single molecule. Drugs Today 2009, 45:483-496.
69. Volkow N.D., Ding Y.S., Fowler J.S., Wang G.J., Logan J., Gatley J.S., Dewey S., Ashby C., Liebermann J., Hitzemann R., Wolf A.P. Is methylphenidate like cocaine? Studies on their pharmacokinetics and distribution in the human brain. Arch. Gen. Psychiatry 1995, 52:456-463.
70. Vorce S.P., Levine B., Mcdonough P.C., Past M.R. An overdose death involving the insufflation of extended-release oxymorphone tablets. J. Anal. Toxicol. 2010, 34:521-526.
71. Webster L. Update on abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med. 2009, 10(Suppl. 2):S124-S133.
72. Webster L., Marie St., Mccarberg B., Passik B., Panchal S.D., Voth S.J.E. Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain. J. Opioid Manage. 2011, 7:235-245.
73. Webster L.R., Fine P.G. Approaches to improve pain relief while minimizing opioid abuse liability. J. Pain 2010, 11:602-611.
74. Wright C., Kramer E.D., Zalman M.A., Smith M.Y., Haddox J.D. Risk identification, risk assessment, and risk management of abusable drug formulations. Drug Alcohol Depend. 2006, 83:S68-S76.