Evaluation of the tamper-resistant properties of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets

References

• Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain 2009;10:113–30
   PubMed Web of Science ®Google Scholar
• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology 2012;116:248–73
   PubMed Web of Science ®Google Scholar
• World Health Organization. WHO’s pain relief ladder. Available at: http://www.who.int/cancer/palliative/painladder/en/ [last accessed 18 Mar 2014]
   Google Scholar
• Gudin JA. Assessment of extended-release opioid analgesics for the treatment of chronic pain. J Pain Palliat Care Pharmacother 2013;27:49–61
   PubMedGoogle Scholar
• Manchikanti L, Fellows B, Ailinani H, Pampati V. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician 2010;13:401–35
   PubMed Web of Science ®Google Scholar
• Butler SF, Black RA, Cassidy TA, et al. Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J 2011;8:29
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. FDA blueprint for prescriber education for extended-release and long-acting opioid analgesics. Rockville (MD): Center for Drug Evaluation and Research; 2013:3292572
   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;20:5–13
   PubMedGoogle Scholar
• Mastropietro DJ, Omidian H. Current approaches in tamper-resistant and abuse-deterrent formulations. Drug Dev Ind Pharm 2013;39:611–24
   PubMed Web of Science ®Google Scholar
• Xartemis™ XR (oxycodone hydrochloride and acetaminophen extended-release tablets). Full prescribing information. Hazelwood (MO): Mallinckrodt Brand Pharmaceuticals, Inc.; 2014
   Google Scholar
• OxyContin® (oxycodone HCl extended release tablets). Full prescribing information. Stamford (CT): Purdue Pharma L.P.; 2011
   Google Scholar
• McCarberg BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther 2001;8:181–6
   PubMedGoogle Scholar
• 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;9:468–79
   PubMed Web of Science ®Google Scholar
• Singla N, Barrett T, Sisk L, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain. Curr Med Res Opin 2014;30:349–59
   PubMed Web of Science ®Google Scholar
• Singla N, Barrett T, Sisk L, et al. Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery. Curr Med Res Opin 2014;30:2571–8
   PubMed Web of Science ®Google Scholar
• FDA Guidance for Industry. Assessment of abuse potential of drugs. Draft guidance. January 2010. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER). Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198650.pdf [last accessed 13 Jun 2014]
   Google Scholar
• Morton T, Kostenbader K, Montgomery J, et al. Comparison of subjective effects of extended-release versus immediate-release oxycodone/acetaminophen tablets: a randomized trial. Postgrad Med 2014;126:20–32
   PubMed Web of Science ®Google Scholar
• Bartholomäus J, Arkenau-Maric E, Galia E. Opioid extended-release tablets with improved tamper-resistant properties. Expert Opin Drug Deliv 2012;9:879–91
   PubMed Web of Science ®Google Scholar
• Vosburg SK, Jones JD, Manubay JM, et al. Assessment of a formulation designed to be crush-resistant in prescription opioid abusers. Drug Alcohol Depend 2012;126:206–15
   PubMed Web of Science ®Google Scholar
• Center for Drug Evaluation and Research. Guidance for industry abuse-deterrent opioids – evaluation and labeling. Silver Spring (MD): U.S. Food and Drug Administration; 2013
   Google Scholar
• Walden M, Nicholls FA, Smith KJ, Tucker GT. The effect of ethanol on the release of opioids from oral prolonged-release preparations. Drug Dev Ind Pharm 2007;33:1101–11
   PubMed Web of Science ®Google Scholar
• Webster LR, Bath B, Medve RA, et al. Randomized, double-blind, placebo-controlled study of the abuse potential of different formulations of oral oxycodone. Pain Med 2012;13:790–801
   PubMed Web of Science ®Google Scholar
• Katz NP, Buse DC, Budman SH, et al. Development and preliminary experience with an ease of extractability rating system for prescription opioids. Drug Dev Ind Pharm 2006;32:727–46
   PubMed Web of Science ®Google Scholar
• Vosburg SK, Jones JD, Manubay JM, et al. A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin(R) (non-TRF) in prescription opioid abusers. Addiction 2013;108:1095–106
   PubMed Web of Science ®Google Scholar
• Maddineni S, Battu SK, Morott J, et al. Formulation optimization of hot-melt extruded abuse deterrent pellet dosage form utilizing design of experiments. J Pharm Pharmacol 2014;66:309–22
   PubMed Web of Science ®Google Scholar
• Hart SG, Cartun RW, Wyand DS, et al. Immunohistochemical localization of acetaminophen in target tissues of the CD-1 mouse: correspondence of covalent binding with toxicity. Fundam Appl Toxicol 1995;24:260–74
   PubMedGoogle Scholar
• OXECTA® (oxycodone HCl, USP). Full prescribing information. Bristol (TN): King Pharmaceuticals; 2011
   Google Scholar
• Schoedel KA, Rolleri RL, Faulknor JY, et al. Assessing subjective and physiologic effects following intranasal administration of a new formulation of immediate release oxycodone HCl (Oxecta) tablets in nondependent recreational opioid users. J Opioid Manag 2012;8:315–27
   PubMedGoogle 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;55:303–4
   PubMed Web of Science ®Google Scholar
• 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;6:300–3
   PubMedGoogle Scholar
• US Food and Drug Administration. FDA Advisory Committee on Reformulated OxyContin. Rockville (MD): Center for Drug Evaluation and Research; 2009
   Google Scholar
• US Food and Drug Administration. Guidance for industry: abuse-deterrent opioids – evaluation and labeling. Silver Spring (MD): Center for Drug Evaluation and Research; 2013
   Google Scholar
• Butler SF, Cassidy TA, Chilcoat H, et al. Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain 2013;14:351–8
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. FDA approves abuse-deterrent labeling for reformulated OxyContin. Rockville (MD): Center for Drug Evaluation and Research; 2013
   Google Scholar
• Cassidy TA, McNaughton EC, Lobo K, et al. Abuse of reformulated OPANA® ER: early findings from NAVIPPRO® data streams. Presented at: American Society of Addiction Medicine 44th Annual Medical-Scientific Conference; 2013 April 25–28; Chicago, IL
   Google Scholar
• US Food and Drug Administration. FDA statement: original Opana ER relisting determination. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm351357.htm [last accessed 22 Jul 2014]
   Google Scholar
• Cassidy TA, DasMahapatra P, Black RA, et al. Changes in prevalence of prescription opioid abuse after introduction of an abuse-deterrent opioid formulation. Pain Med 2014;15:440–51
   PubMed Web of Science ®Google Scholar
• Cicero TJ, Ellis MS, Surratt HL. Effect of abuse-deterrent formulation of OxyContin. N Engl J Med 2012;367:187–9
   PubMed Web of Science ®Google Scholar
• Drug Abuse Warning Network. US Department of Health and Human Services. Available at: https://dawninfo.samhsa.gov/default.asp [last accessed 2 Jun 2010]
   Google Scholar
• The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System. Denver Health. Available at: http://www.radars.org/ [last accessed 30 Oct 2014]
   Google Scholar
• National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO). Inflexxion, Inc. Available at: http://inflexxion.com/data_analysis_services/ [last accessed 30 Oct 2014]
   Google Scholar