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

Bibliography

• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• Ehrlich GE. Back pain. J Rheumatol Suppl 2003;67:26-31
   PubMedGoogle Scholar
• Strassels S. Economic burden of prescription opioid misuse and abuse. J Manag Care Pharm 2009;15(7):556-62
   PubMed Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• Manchikanti L, Helm Ii S, Fellows B, Opioid Epidemic in the United States. Pain Physician 2012;15(3 Suppl):ES9-38
   PubMed Web of Science ®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):683-94
   PubMed Web of Science ®Google Scholar
• Bhamb B, Brown D, Hariharan J, 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Trescot AM, Boswell MV, Atluri SL, Opioid guidelines in the management of chronic non-cancer pain. Pain Physician 2006;9:1-39
   PubMedGoogle Scholar
• 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
   Google Scholar
• Gilson AM, Kreis PG. The burden of the nonmedical use of prescription opioid analgesics. Pain Med 2009;10(Suppl 2):S89-100
   PubMed Web of Science ®Google Scholar
• 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]
   Google Scholar
• Webster L, St. Marie B, McCarberg B, Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain. J Opioid Manage 2011;7(3):235-45
   PubMedGoogle Scholar
• Yap D. FDA approves final ER/LA opioid analgesic REMS. Pharm Today. 2012. Available from: http://www.pharmacist.com/fda-approves-final-erla-opioid-analgesic-rems [Accessed 1 August 2012]
   Google Scholar
• Barthwell AG, Barnes MC, Leopold VR, 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]
   Google Scholar
• 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]
   Google Scholar
• 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]
   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
• 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
   Google Scholar
• Wang HY, Friedman E, Olmstead MC, 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
   PubMed Web of Science ®Google Scholar
• Webster LR, Butera PG, Moran LV, Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain 2006;7(12):937-46
   PubMed Web of Science ®Google Scholar
• Webster L. Update on abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med 2009;10:S124-33
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Sunshine A, Axtmayer R, Olson NZ, Analgesic efficacy of pentazocine versus pentazocine-naloxone combination following oral administration. Clin J Pain 1988;3:35-40
   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):303-4
   PubMed Web of Science ®Google Scholar
• Ruan X, Chen T, Gudin J, 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
   PubMedGoogle Scholar
• Katz N, Sun S, Johnson F, 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
   PubMed Web of Science ®Google Scholar
• Stauffer J, Setnik B, Sokolowska M, 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
   PubMed Web of Science ®Google Scholar
• Webster L, Jones JB, Johnson F, 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
   Google Scholar
• Embeda recall issued due to ongoing manufacturing problems. Available from: http://www.aboutlawsuits.com/embeda-recall-manufacturing-problems-16891 [Accessed 3 August 2012]
   Google Scholar
• DrugWatch. Pain drug Embeda recalled due to defect in formula. Available from: http://www.reuters.com/article/2011/03/16/pfizer-recall-idUSN1618366120110316 [Accessed 3 August 2012]
   Google Scholar
• 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]
   Google Scholar
• OXECTA® Full Prescribing Information. King Pharmaceuticals, Inc; Bristol, TN: 2011. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=62 [Accessed 3 August 2012].
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   Google Scholar
• Daniels SE, Spivey RJ, Singla S, 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
   PubMed Web of Science ®Google Scholar
• 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-letter-king-pharmaceuticals-fda-response [Accessed 12 July 2012]
   Google Scholar
• 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]
   Google Scholar
• Cicero TJ, Ellis MS, Surratt HC. Effect of abuse-deterrent formulation of Oxycontin. N Engl J Med 2012;367:187-9
   PubMed Web of Science ®Google Scholar
• Butler SF, Cassidy TA, Chilcoat H, 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
   PubMed Web of Science ®Google Scholar
• Galia E, Schwier S, Lehrach I, 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Fiske WD, Jobes J, Xiang Q, 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
   PubMed Web of Science ®Google Scholar
• Schoedel KA, McMorn S, Chakraborty B, 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
   PubMedGoogle Scholar
• Vallejo R, Bark RL, Wang VC. Pharmacology of opioids in the treatment of chronic pain syndromes. Pain Physician 2011;14(4):E343-60
   PubMed Web of Science ®Google Scholar
• Butler S, Black R, Cassidy T, 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
   Google Scholar
• 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]
   Google Scholar
• Fleming AB, Noonan PK, Schiller M, 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
   Google Scholar
• 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]
   Google Scholar
• Ridgway D, Sopata M, Burneckis A, 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
   PubMed Web of Science ®Google Scholar
• Brennan MJ, Stanos S. Strategies to optimize pain management with opioids while minimizing risk of abuse. PMR 2010;2(6):544-58
   PubMedGoogle Scholar
• 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]
   Google Scholar
• Palladone for chronic pain. Med Lett Drugs Ther 2005;47:21-3
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• de Kater A, Butera P, Haux JE, 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
   Google Scholar
• Butler SF, Black R, Grimes-Serrano JM, 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
• Merrigan T, Friedmann N, Butera P, 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
   Google Scholar
• 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]
   Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Butler SF, Budman SH, Fernandez KC, Development and validation of the Current Opioid Misuse Measure. Pain 2007;130:144-56
   PubMed Web of Science ®Google Scholar
• Butler SF, Budman SH, Fernandez K, Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain 2008;9:360-72
   PubMed Web of Science ®Google Scholar