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Abuse-deterrent opioid formulations have been suggested as one way to decrease the abuse, addiction, and overdose of orally prescribed opioids. Ten oral opioid formulations have received abuse-deterrent labeling by the U.S. Food and Drug Administration (FDA). Their properties consist of physical and/or chemical means by which the pills resist manipulation and create a barrier to unintended administration, such as chewing, nasal snorting, smoking, and intravenous injection. In this review, we describe the mechanisms of abuse-deterrent technology, the types of premarketing studies required for FDA approval, the pharmacology of the currently approved abuse-deterrent opioid formulations, and the evidence for and against their influence on opioid abuse. We conclude that there is currently insufficient evidence to indicate that the availability of abuse-deterrent opioid formulations has altered the trajectory of opioid overdose and addiction; however, postmarketing studies are in their infancy, and novel deterrent formulations are continually being developed and submitted for marketing approval.

The introduction of extended-release opioid analgesics helped initiate an epidemic of prescription opioid abuse in the United States. To make access to the drug by crushing or dissolution more difficult, abuse-deterrent formulations (ADFs) of OxyContin (Purdue Pharma, Stamford, CT) and Opana ER (Endo Pharmaceuticals Inc., Malvern, PA), which use the same foundation technology (Intac, Grunenthal, Aachen, Germany), were introduced in 2010 and 2012, respectively. To examine their relative effectiveness, we used a structured survey of 12,124 individuals entering treatment for opioid use disorder followed by a more focused online survey with a subset of these patients (N = 129) using both structured and open-ended questions. Data showed that the OxyContin ADF was highly effective in reducing nonoral abuse (91.4% before the ADF, 47.9% afterwards), particularly with insufflation (78%-28.8%) and intravenous injection of the active drug (42.7%-21.4%). However, although the Opana ER ADF was effective in reducing insufflation (80%-37.1%), injection (60.0%-51.4%), and overall nonoral abuse (94.3%-77.1%), it showed no significant decrease over time. Bearing in mind that the Opana ER sample was smaller in size than that for OxyContin, our results nonetheless suggest disparate outcomes resulting from the introduction of the ADFs, which could indicate that an ADF's effectiveness may be drug-specific. Given the public health impact of prescription opioids and the considerable effort being expended to develop ADFs as a partial solution to the problem, our preliminary studies suggest that each ADF must be evaluated on its own merits even if the same proprietary technology is used.

The purpose of the present study was to identify the factors that influence the selection of hydrocodone and oxycodone as primary drugs of abuse in opioid-dependent subjects (n = 3520) entering one of 160 drug treatment programs around the country. Anonymous, self-administered surveys and direct qualitative interviews were used to examine the influence of demographic characteristics, drug use patterns, and decision-related factors on primary opioid selection. Our results showed that oxycodone and hydrocodone were the drugs of choice in 75% of all patients. Oxycodone was the choice of significantly more users (44.7%) than hydrocodone (29.4%) because the quality of the high was viewed to be much better by 54% of the sample, compared to just 20% in hydrocodone users, who cited acetaminophen as a deterrent to dose escalation to get high and hence, its low euphoric rating. Hydrocodone users were generally risk-averse women, elderly people, noninjectors, and those who prefer safer modes of acquisition than dealers (ie, doctors, friends, or family members). In contrast, oxycodone was a much more attractive euphorigenic agent to risk-tolerant young, male users who prefer to inject or snort their drugs to get high and are willing to use more aggressive forms of diversion. Prevention and treatment approaches, and pain physicians, should benefit from these results because it is clear that not all drug abusers share the same characteristics, and the decision to use one drug over another is a complex one, which is largely attributable to individual differences (eg, personality, gender, age, and other factors)., (Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.)

We used a large medical insurance claims database to identify three groups: chronic opioid use (>180 therapeutic days, N=3726); acute opioid use (<10 therapeutic days, N=37,108); and a non-opioid group (N=337,366) who filed at least one insurance claim but none for opioids. Our results showed that although chronic opioid users represented only 0.65% of the total population, they filed 4.56% of all insurance claims, used 45% of all opioid analgesics and had much more physical and psychiatric co-morbidity than the acute opioid or non-opioid samples. Women were substantially over-represented (>63%) in the chronic pain group and used a much greater share of all medical services than males, especially as they grew older. Although our data suggest that chronic pain is optimally managed in a multidisciplinary patient- and gender-specific treatment plan, this was rarely the case with internists being the primary, and often only, physician seen. Moreover, our data suggest that opioids were often used for conditions in which they are generally not indicated (e.g. arthritis and headaches) or contraindicated by co-existing physical ailments (COPD). Finally, we conclude that adherence to the WHO analgesic ladder and other pain treatment guidelines was relatively infrequent: first, opioid extended release preparations which are ideally suited for chronic pain were used only in one in four patients; and, second, the selection of a weak (propoxyphene, codeine, and tramadol) or strong opioid (e.g. morphine and oxycodone) seemed to be driven by numerous factors not necessarily related to the intensity or duration of pain.

The purpose of this study was to identify co-morbidity in a national sample (N=1408) of males and females entering treatment for opioid abuse. Our sample was primarily white, lived in small urban, suburban or rural locations (80%), and was well-educated. Chronic pain was a symptomatic feature in over 60% of all subjects. Furthermore, 79% of male and 85% of female prescription opioid abusers indicated that their first exposure to an opioid was a legitimate prescription for pain which subsequently led 60-70% to misuse to get high. Our data also indicate that the use of prescription opioids to get high represents the end stage on a continuum of substance abuse, beginning at a very early age. The age of first alcohol use, getting drunk, smoking, use of marijuana, stimulants and other non-opioid prescription or illicit drugs occurred very early (13-19) in prescription opioid misusers/abusers, whose first use of opioids did not occur, on average, until age 22. Finally, most of the sample had sought treatment 3 or more times for substance abuse prior to the treatment admission in which the survey was completed. Physical and mental health were very poor in both male and female prescription opioid abusers, but females were more ill and dysfunctional than males in all physical and particularly emotional domains. Our results suggest that a small number of "at risk" opioid naive pain patients, who might abuse their therapeutically appropriate opioid analgesics, can be identified by assessing pre- and co-morbid substance abuse and significant psychopathology.