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Issue 1, Volume 3
Abuse-Deterrent Technologies
14 Articles in this Series
The effect of a potentially tamper-resistant oxycodone
Commentary: Why Prescribers Need to Adopt Abuse-Deterrent Opioids
Review: The Impact of Abuse-Deterrent Formulations on Prescribing and Abuse
Abuse-Deterrence Guidance Further Highlights Federal Focus
The Burden of Undiagnosed Opioid Abuse Among the Commercially Insured
Reductions in Reported Deaths Following Introduction of Abuse-Deterrent Oxycodone ER (OxyContin)
Abuse-Deterrent Opioids—Evaluation and Labeling
Generic patches containing fentanyl: abuse deterrent evaluation
FDA Advisory Committee Meetings on Abuse-Deterrent Opioids
Regulatory Update: FDA Takes Additional Abuse-Deterrent Steps
Related: At-Risk Patients and Urine Drug Monitoring
Extended-Release Formulations Enter US Market
Development and Impact of Prescription Opioid ADF Technologies
Trends in Opioid Analgesic Abuse and Mortality in the United States

Commentary: Why Prescribers Need to Adopt Abuse-Deterrent Opioids

Available and evolving abuse-deterrent technologies offer a path away from abuse, misuse, and diversion.
2018;Pract Pain Manage. 2018:18(2):57-59

As states and physicians scramble to meet the CDC opioid guidelines,1 they might keep in mind that more options are available for helping to reduce opioid abuse and misuse among patients than just changing prescribing patterns. While not all abuse, misuse, and diversion can be deterred, abuse-deterrent opioids (ADOs) offer a shift away from the deadliest forms of opioid misuse – intranasal and intravenous abuse. The most serious safety events and addiction-related deaths occur via these methods, at an approximately 2.5 times greater prevalence rate than oral abuse.2

Types of Deterrent Formulations & Technologies

For the estimated 11% of adults who experience daily pain,3 as well as the millions of Americans who manage acute pain with prescription opioids, ADOs provide an additional layer of risk prevention. ADO formulations are designed to deter dose tampering, increase the time and energy required to remove extended-release capabilities, and decrease/limit the reward (ie, quick high) of the opioid. While there are a variety of abuse-deterrent formulation (ADF) approaches, there are three chief methods in use or under development that promise to address different abuse activities:

• Physiochemical barriers: These barriers use ingredients and manufacturing technology to make the product resistant to crushing, chewing, and gelling. As a result, the tablets cannot be broken down into a powder fine enough to ingest via the nasal route, and if dissolving is attempted, then the formulation transforms into a gel-like mass, which makes it difficult to push through the needle of a typical syringe. Example: OxyContin.

• Pharmacological barriers: It is known that opioids work by attaching themselves to receptors in the body. By embedding antagonists into the pill, the effect of the narcotic is blocked when abused (eg, when crushing or dissolving), while still releasing the appropriate medication. Example: Hysingla.

• Prodrugs: These formulations are inactive, bioreversible derivatives of active drug molecules that must undergo an enzymatic or chemical transformation to release the parent drug, which can then elicit its desired pharmacological effect in the body. For example, when a prodrug tablet reaches the intestines, enzymes in the digestive system cause the release of the active ingredient as prescribed. Prodrugs aim to help prevent the rapid euphoria that abusers seek by disincentivizing intranasal or intravenous abuse. Example: aspirin. The first immediate-release produg with abuse-deterrent properties may soon receive FDA approval.

Table I lists the 10 currently FDA-approved abuse-deterrent opioids, some of which are still pending commercialization.


What to Expect from Abuse-Deterrent Opioids

Abuse-deterrent formulations of opioids may be the most substantive contribution to the fight against prescription drug abuse that pharmaceutical technology innovators are offering at this time. Clinicians adding these products to their treatment armamentarium, however, must align their expectations with the products’ technological capabilities. For starters, prescribers should be aware that ADF technologies are either additive to a therapeutic moiety or represent a new molecular entity (NME). The presence of an ADF within an ADO has no impact on the designed therapeutic benefit of the opioid.

While ADOs are capable of preventing abuse, they are not expected to prevent abuse of DEA scheduled products, but rather, aim to lower the abuse potential of those products. Their formulations were largely designed to target the opioid naive patient and early stage recreational abusers; the technology may not effectively deter a professional manipulator, a desperate addict, or an experienced abuser. Abuse-deterrent opioids with ADF technologies should, therefore, be considered part of a multifactorial e ort to deter a patient from progressing from potential abuse, misuse, or diversion to the more lethal intranasal/intravenous forms of abuse.

Furthermore, it is important to be aware that ADOs are both equally effective and equally as dangerous as current non-ADOs. The risk of death or a severe adverse event of any opioid is unchanged by the addition of, or lack of, an abuse-deterrent formulation. There are no products on the market yet that claim to reduce abuse by swallowing – and no abuse-deterrent technology provides 100% risk protection.

Read more in the March 2018 issue of Practical Pain Management, including “Why Add ADOs to Your Armamentarium?”


Next Article:
Review: The Impact of Abuse-Deterrent Formulations on Prescribing and Abuse
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