Assessment of the abuse of tapentadol immediate release: The first 24 months

Richard C. Dart, MD, PhD; Theodore J. Cicero, PhD; Hilary L. Surratt, PhD; Andrew Rosenblum, PhD; Becki Bucher Bartelson, PhD; Edgar H. Adams, ScD

doi:10.5055/jom.2012.0139

Authors

Richard C. Dart, MD, PhD
Theodore J. Cicero, PhD
Hilary L. Surratt, PhD
Andrew Rosenblum, PhD
Becki Bucher Bartelson, PhD
Edgar H. Adams, ScD

DOI:

https://doi.org/10.5055/jom.2012.0139

Keywords:

tapentadol, opioid, abuse, diversion, RADARS

Abstract

Objective: Prescription opioid analgesics play an important role in the management of moderate to severe pain. An unintended consequence of prescribing opioid analgesics is the abuse and diversion of these medications. The authors estimated abuse and diversion rates for tapentadol immediate release (IR) compared with oxycodone, hydrocodone, and tramadol during the first 24 months of tapentadol IR availability.

Methods: The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) System measures rates of prescription opioid abuse and diversion throughout the United States. Quarterly data from the Poison Center, Drug Diversion, Opioid Treatment, and Survey of Key Informants’ Patients (SKIP) programs were plotted to visually compare the rates of tapentadol IR abuse and diversion with those of other opioid analgesics from July 2009 through June 2011 using both cases per 100,000 population and per 1,000 unique recipients of dispensed drug (URDD) as denominators. Trends in abuse and diversion rates over time were determined using a linear regression model of rate versus time.

Results: During the 24 months following its introduction, tapentadol IR had very low population-based rates of abuse and diversion that were similar to rates for tramadol and lower than rates for oxycodone and hydrocodone. Rates of tapentadol IR abuse and diversion based on URDD were variable by program due to changes in market share and had not stabilized as of June 2011.

Conclusions: Rates of tapentadol IR abuse and diversion have been low during the first 24 months after its launch. Continued monitoring of trends in these data is warranted.

Author Biographies

Richard C. Dart, MD, PhD

Rocky Mountain Poison and Drug Center, Denver, Colorado; Department of Emergency Medicine, University of Colorado, Denver, Colorado

Theodore J. Cicero, PhD

Washington University School of Medicine, St. Louis, Missouri

Hilary L. Surratt, PhD

Nova Southeastern University, Fort Lauderdale, Florida

Andrew Rosenblum, PhD

Institute for Treatment and Services Research, National Development and Research Institutes, Inc., New York, New York

Becki Bucher Bartelson, PhD

Rocky Mountain Poison and Drug Center, Denver, Colorado

Edgar H. Adams, ScD

Covance Market Access, Gaithersburg, Maryland

References

Brennan MJ, Stanos S: Strategies to optimize pain management with opioids while minimizing risk of abuse. PMR. 2010; 2(6): 544-558.

Ruetsch C: Empirical view of opioid dependence. J Manag Care Pharm. 2010; 16(1 Suppl B): S9-S13.

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. Available at http://www.oas.samhsa.gov/NSDUH/2k9NSDUH/2k9ResultsP.pdf. Accessed September 1, 2012.

Ling W, Mooney L, Hillhouse M: Prescription opioid abuse, pain and addiction: Clinical issues and implications. Drug Alcohol Rev. 2011; 30(3): 300-305.

Inciardi JA, Surratt HL, Cicero TJ, et al.: Prescription opioid abuse and diversion in an urban community: The results of an ultrarapid assessment. Pain Med. 2009; 10(3): 537-548.

US Food and Drug Administration: March 3, 2009 industry meeting on Risk Evaluation and Mitigation Strategy (REMS) for certain opioid drugs. Available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163660.htm. Accessed December 7, 2011.

Tzschentke TM, Christoph T, Kögel B, et al.: (—)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): A novel _-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007; 323(1): 265-276.

Nucynta® (tapentadol) immediate-release oral tablets [package insert]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc., 2011.

Palexia® (tapentadol) oral film-coated tablets [summary of product characteristics]. Aachen, Germany: Grünenthal GmbH, 2011.

US Department of Justice Drug Enforcement Administration Office of Diversion Control: Controlled substance schedules. Available at http://www.deadiversion.usdoj.gov/schedules/index.html. Accessed September 1, 2012.

Tzschentke TM, De Vry J, Terlinden R, et al.: Tapentadol hydrochloride. Analgesic, mu-opioid receptor agonist, noradrenaline reuptake inhibitor. Drugs Future. 2006; 31(12): 1053-1061.

Candiotti KA, Gitlin MC: Review of the effect of opioid-related side effects on the undertreatment of moderate to severe chronic non-cancer pain: Tapentadol, a step toward a solution? Curr Med Res Opin. 2010; 26(7): 1677-1684.

RADARS® System homepage. Available at http://www.radars.org/. Accessed September 1, 2012.

Cicero TJ, Dart RC, Inciardi JA, et al.: The development of a comprehensive risk-management program for prescription opioid analgesics: Researched abuse, diversion and addiction-related surveillance (RADARS). Pain Med. 2007; 8(2): 157-170.

Hughes AA, Bogdan GM, Dart RC: Active surveillance of abused and misused prescription opioids using poison center data: A pilot study and descriptive comparison. Clin Toxicol (Phila). 2007; 45(2): 144-151.

Smith MY, Dart R, Hughes A, et al.: Clinician validation of Poison Control Center (PCC) intentional exposure cases involving prescription opioids. Am J Drug Alcohol Abuse. 2006; 32(3): 465-478.

Bailey JE, Barton PL, Lezotte D, et al.: The effect of FDA approval of a generic competitor to OxyContin (oxycodone HCl controlled-release) tablets on the abuse of oxycodone. Drug Alcohol Depend. 2006; 84(2): 182-187.

Bailey JE, Campagna E, Dart RC, et al.: The under-recognized toll of prescription opioid abuse on young children. Ann Emerg Med. 2009; 53(4): 419-424.

Inciardi J, Surratt H, Lugo Y, et al.: The diversion of prescription opioid analgesics. Law Enforc Exec Forum. 2007; 7(7): 127-141.

Inciardi JA, Cicero TJ, Munoz A, et al.: The diversion of Ultram®, Ultracet®, and generic tramadol HCl. J Addict Dis. 2006; 25(2): 53-58.

Rosenblum A, Parrino M, Schnoll SH, et al.: Prescription opioid abuse among enrollees into methadone maintenance treatment. Drug Alcohol Depend. 2007; 90(1): 64-71.

Cleland CM, Rosenblum A, Fong C, et al.: Age differences in heroin and prescription opioid abuse among enrolees into opioid treatment programs. Subst Abuse Treat Prev Policy. 2011; 6:11.

Cicero TJ, Inciardi JA, Munoz A: Trends in abuse of oxycontin and other opioid analgesics in the United States: 2002-2004. J Pain. 2005; 6(10): 662-672.

Cicero TJ, Inciardi JA, Adams EH, et al.: Rates of abuse of tramadol remain unchanged with the introduction of new branded and generic products: Results of an abuse monitoring system, 1994-2004. Pharmacoepidemiol Drug Saf. 2005; 14(12): 851-859.

Cicero TJ, Surratt H, Inciardi JA, et al.: Relationship between therapeutic use and abuse of opioid analgesics in rural, suburban, and urban locations in the United States. Pharmacoepidemiol Drug Saf. 2007; 16(8): 827-840.

Smith MY, Schneider MF, Wentz A, et al.: Quantifying morbidity associated with the abuse and misuse of opioid analgesics: A comparison of two approaches. Clin Toxicol (Phila). 2007; 45(1): 23-30.

Schneider MF, Bailey JE, Cicero TJ, et al.: Integrating nine prescription opioid analgesics and/or four signal detection systems to summarize statewide prescription drug abuse in the United States in 2007. Pharmacoepidemiol Drug Saf. 2009; 18(9): 778-790.

Adams EH, Breiner S, Cicero TJ, et al.: A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain. J Pain Symptom Manage. 2006; 31(5): 465-476.

Cicero TJ, Adams EH, Geller A, et al.: A postmarketing surveillance program to monitor Ultram (tramadol hydrochloride) abuse in the United States. Drug Alcohol Depend. 1999; 57(1): 7-22.

WHO Expert Committee on Drug Dependence: WHO Technical Report Series, No. 915 (2003; 31 pp). Available at http://apps.who.int/medicinedocs/pdf/s4896e/s4896e.pdf Accessed September 1, 2012.

WHO Expert Committee on Drug Dependence: 34th Meeting 2006/4.5. Assessment of tramadol. Available at http://www.who.int/medicines/areas/quality_safety/5.2TramadolCritReview.pdf. Accessed September 1, 2012.

Baker DA, Tran-Nguyen TL, Fuchs RA, et al.: Influence of individual differences and chronic fluoxetine treatment on cocaine-seeking behavior in rats. Psychopharmacology (Berl). 2001; 155(1): 18-26.

Carroll ME, Lac ST, Asencio M, et al.: Fluoxetine reduces intravenous cocaine self-administration in rats. Pharmacol Biochem Behav. 1990; 35(1): 237-244.

Foltin RW, Ward AS, Collins ED, et al.: The effects of venlafaxine on the subjective, reinforcing, and cardiovascular effects of cocaine in opioid-dependent and non-opioid-dependent humans. Exp Clin Psychopharmacol. 2003; 11(2): 123-130.

Lu L, Su WJ, Yue W, et al.: Attenuation of morphine dependence and withdrawal in rats by venlafaxine, a serotonin and noradrenaline reuptake inhibitor. Life Sci. 2001; 69(1): 37-46.

Magalas Z, De Vry J, Tzschentke TM: The serotonin/noradrenaline reuptake inhibitor venlafaxine attenuates acquisition, but not maintenance, of intravenous self-administration of heroin in rats. Eur J Pharmacol. 2005; 528(1-3): 103-109.

Yu DS, Smith FL, Smith DG, et al.: Fluoxetine-induced attenuation of amphetamine self-administration in rats. Life Sci. 1986; 39(15): 1383-1388.

US Department of Health and Human Services Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality: Drug Abuse Warning Network, 2008: National Estimates of Drug-Related Emergency Department Visits. Available at http://www.oas.samhsa.gov/DAWN/2K8/ED/DAWN2k8ED.pdf. Accessed September 1, 2012.

Drug Enforcement Administration Office of Diversion Control: NFLIS National Forensic Laboratory Information System Year 2010 Annual Report. Available at http://www.deadiversion.usdoj.gov/nflis/2010annual_rpt.pdf Accessed September 1, 2012.

Drug Enforcement Administration Office of Diversion Control: NFLIS National Forensic Laboratory Information System Year 2009 Annual Report. Available at http://www.deadiversion.usdoj.gov/nflis/2009annual_rpt.pdf. Accessed September 1, 2012.