The Medical Letter on Drugs and Therapeutics
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1522
Abuse-Deterrent Opioids
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Revised 6/14/18: Targiniq ER has been removed from Table 1.

Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Since our last article on this subject,1 several new abuse-deterrent opioid formulations have been approved by the FDA,2,3 including an oxycodone tablet formulation (Roxybond – Inspirion) that is the first immediate-release opioid product FDA-approved to include claims of abuse deterrence in its labeling.4 No opioid formulation prevents consumption of a large number of intact dosage units, the most common method of abuse. Abuse-deterrent formulations have one or more properties that make their intentional nontherapeutic use more difficult, less attractive, or less rewarding.5

LABELING REQUIREMENTS — For claims of abuse deterrence to be included in the labeling of an opioid formulation, the FDA requires that laboratory tests first be performed to assess how easily the abuse-deterrent properties of the formulation can be compromised. In vivo studies that compare the pharmacokinetic profiles of the formulation before and after manipulation should then be conducted. Based on these results, a randomized, double-blind, placebo- and active-controlled study should evaluate the subjective effects of the formulation, such as differences in "drug liking" in recreational drug users.

Postmarketing epidemiological studies that assess whether a formulation has been associated with meaningful reductions in adverse clinical outcomes related to abuse and misuse are required for all opioid formulations that have claims of abuse deterrence in their labeling.

EFFECTIVENESS — Whether the availability of single-source, abuse-deterrent opioid products will result in a reduction in overall opioid abuse remains to be determined. In postmarketing studies, reformulation of an extended-release oxycodone formulation (Oxycontin) to include abuse-deterrent properties has been associated with reduced rates of prescription sales, abuse, and diversion of the product. It has also reduced doctor shopping for Oxycontin, the number of reported cases of Oxycontin poisonings and overdose fatalities, and the street price of the product.6-9 Some of these studies, however, reported increased abuse of other opioids, including heroin.10-12

COST — Some insurers do not cover abuse-deterrent opioid formulations because they cost more than standard opioid formulations. No generic opioids are FDA-approved to include claims of abuse deterrence in their labeling.

AVAILABILITY — Like their older counterparts, opioids approved to include claims of abuse deterrence in their labeling are classified as schedule II controlled substances (highest potential for abuse; recognized medical use).

REMS — As part of a Risk Evaluation and Mitigation Strategy (REMS) program, the FDA has required the manufacturers of all long-acting opioids to make educational programs available to prescribers.

CONCLUSION — Whether the availability of single-source, abuse-deterrent opioid products reduces overall opioid abuse remains to be determined. These products are relatively expensive, and they have no generic equivalents.

  1. Abuse-deterrent opioid formulations. Med Lett Drugs Ther 2015; 57:119.
  2. A new abuse-deterrent opioid – Xtampza ER. Med Lett Drugs Ther 2016; 58:77.
  3. Arymo ER – a new abuse-deterrent morphine formulation. Med Lett Drugs Ther 2017; 59:68.
  4. An abuse-deterrent IR oxycodone formulation (Roxybond). Med Lett Drugs Ther 2017; 59 (in press).
  5. FDA. Abuse-deterrent opioids – evaluation and labeling: guidance for industry. April 2015. Available at: www.fda.gov. Accessed May 25, 2017.
  6. L Degenhardt et al. The introduction of a potentially abuse deterrent oxycodone formulation: early findings from the Australian National Opioid Medications Abuse Deterrence (NOMAD) study. Drug Alcohol Depend 2015; 151:56.
  7. PM Coplan et al. Changes in oxycodone and heroin exposures in the National Poison Data System after introduction of extended-release oxycodone with abuse-deterrent characteristics. Pharmacoepidemiol Drug Saf 2013; 22:1274.
  8. TJ Cicero et al. Effect of abuse-deterrent formulation of OxyContin. N Engl J Med 2012; 367:187.
  9. TA Cassidy et al. Changes in prevalence of prescription opioid abuse after introduction of an abuse-deterrent opioid formulation. Pain Med 2014; 15:440.
  10. MR Larochelle et al. Rates of opioid dispensing and overdose after introduction of abuse-deterrent extended-release oxycodone and withdrawal of propoxyphene. JAMA Intern Med 2015; 175:978.
  11. CS Hwang et al. Impact of abuse-deterrent OxyContin on prescription opioid utilization. Pharmacoepidemiol Drug Saf 2015; 24:197.
  12. PM Coplan et al. The effect of an abuse-deterrent opioid formulation (OxyContin) on opioid abuse-related outcomes in the postmarketing setting. Clin Pharmacol Ther 2016; 100:275.
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