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

Abstract

Numerous concerns with the integration of these formulations into clinical practice remain, as no product is intended or capable of addressing all types of misuse or abuse. As a result, these formulations should not necessarily be considered preferred agents once available in clinical practice. Moreover, before initiating therapy with abuse-deterrent and tamper-resistant formulations, proper patient assessment to identify risk factors for misuse and abuse should be implemented and optimized. With screening and monitoring in place, it would then be sensible to consider these formulations in patients who appear to be at high risk of misuse, abuse and/or diversion.

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

“…[94][95][96][97][98][99][100] Available abuse-deterrent formulations aim to hinder extraction of the active ingredient, limit its bioavailability, prevent administration through alternative routes and/or make abuse of the manipulated product much less attractive, less rewarding or even aversive. Possible approaches to abuse deterrence include physical and chemical barriers to prevent manipulation of the formulation and extraction of the active ingredient, combination with an antagonist, aversion technologies, use of new molecular entities or prodrugs, and novel delivery systems.…”

“…Some other currently available opioid analgesics have also been reported to have potential abuse-deterrent properties; however, these have not yet met the necessary regulatory requirements for an ADF label. [94][95][96][97][98][99] A growing body of evidence suggests that introduction of the abuse-deterrent formulation of oxycodone has been associated with decreased rates of abuse and diversion of this opioid analgesic in the USA. [101,[110][111][112][113][114][115][116][117][118][119].…”

The Clinical Applications of Extended-Release Abuse-Deterrent Opioids

“…While treating patients, it is important first to determine whether opioids should play a role in the treatment of pain. Next, the reason for the need for abuse-deterrent opioids should be identified, which is the risk for misuse or abuse [63]. It is necessary to continue clinical research, with more outcomebased studies evaluating the long-term efficacy of abusedeterrent opioids needed.…”

Designing a tool allowing for a standardized assessment of resistance to drug diversion

“…Drug abuse with tampering (drug diversion) is a growing problem in many countries [7][8][9]. This problem has most often been reported with opioids [3,5,[10][11][12][13].…”

“…The problem for healthcare authorities is now to assess new formulations developed to limit the risk of diversion of administration mode and/or chemical submission so as to determine to what extent these risks are limited [2,3,7,13,16,[18][19][20]22,25,27,[36][37][38][39][40][41][42][43][44][45][46][47]. Recently, the FDA published a draft guidance for industry for the evaluation and labeling of abuse deterrent opioids.…”