Abuse-Deterrent Opioid Formulations: A Key Ingredient in the Recipe to Prevent Opioid Disasters?

Abstract

The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route. Despite these and other technologies, consensus regarding the effectiveness of these formulations in preventing non-medical use is lacking given the difficulty in obtaining post-marketing data. Researchers also question if the creation of abuse-deterrent drugs will have a positive effect on those struggling with a severe opioid-use disorder, fearing that current opioid users will simply find a new - perhaps more dangerous - drug of choice. Abuse-deterrent opioids are still opioids, and although they may make manipulation more difficult than non-ADF formulations, they are not "abuse proof." The introduction of ADFs could provide a false sense of security among prescribers and dispensers, and we fear that ADFs may have a minimal impact on non-medical use of prescription opioids. Further epidemiological studies will be required to determine the large-scale impact of abuse-deterrent opioids in preventing opioid use disorder and its downstream consequences.

Tapentadol Prolonged Release: A Review in Pain Management

“…Various measures can be implemented to reduce the inappropriate use of opioids, among which are abuse-deterrent formulations [52], with such formulations being available for tapentadol and various other opioids in certain markets [52]. Although abuse-deterrent opioid formulations are an important step in addressing the manipulation of opioids for non-oral use, their large-scale impact in preventing opioid abuse remains to be determined [52].…”

Advances in Achieving Opioid Analgesia Without Side Effects

“…This has been attempted by means of physical or chemical barriers to hinder crushing, chewing, or solubilization of pills, as in case of modifications of morphine (MorphaBond ER, Arymo ER), oxycodone (OxyContin, RoxyBond, Xtampza ER), and hydrocodone (Vantrela ER, Hyslinga ER). Alternatively, opioid receptor agonists were combined with antagonists, as in case of Embeda (morphine and naltrexone), Troxyca ER (oxycodone and naltrexone), or Targiniq ER (oxycodone and naloxone) ( Becker and Fiellin, 2017 ; Salwan et al, 2018 ). However, these strategies have not proved successful in preventing opioid abuse.…”

“…However, these strategies have not proved successful in preventing opioid abuse. To overcome the obstacles associated with hindering the misuse of these formulations they were taken at higher doses or replaced with other opioids having a higher abuse liability such as heroin or fentanyl ( Cicero and Ellis, 2015 ; Becker and Fiellin, 2017 ; Curfman et al, 2018 ; Salwan et al, 2018 ).…”

Causal inference for evaluating prescription opioid abuse using trend‐in‐trend design

“…These routes can increase risks for infections and may elevate risks for addiction and overdose . Opioid analgesics with abuse deterrent properties have proven hard to evaluate, and more rigorous epidemiologic methods are needed …”

“…3 Opioid analgesics with abuse deterrent properties have proven hard to evaluate, [4][5][6][7][8] and more rigorous epidemiologic methods are needed. [9][10][11] Previous studies have used interrupted time-series comparing abuse rates before and after tamper-resistant reformulations of existing drugs. [12][13][14][15][16][17][18][19][20][21][22][23] For example, studies evaluating the reformulation of extended-release oxycodone reported relative reductions in abuse ranging from 22% 18 to 83%.…”