Opioid Abuse-Deterrent Formulation Strategies in Opioid Risk Management

Opioid abuse-deterrent formulations (ADFs) represent 1 aspect of an opioid risk management plan that is aimed at managing a patient’s pain relief and quality of life while also protecting against harmful outcomes of opioid misuse. A report, published by the Journal of Multidisciplinary Healthcare, outlined ADF types and strategies and concluded all stakeholders play a role and must cooperate with opioid risk management in order to be effective.

The authors explained that ADFs are designed to be therapeutically equivalent to the original formulation of the opioid in terms of dose, clinical efficacy, and safety, while also reducing the desirability of the opioid.

“In a 2008 Senate Health Committee meeting, the Centers for Disease Control and Prevention recommended that 'drug manufacturers should modify opioid painkillers so that they are more difficult to tamper with and/or combine them with agents that block the effect of the opioid if it is dissolved and injected,'” said the authors. “The use of opioid ADFs is one part of the solution to this public health issue.”

Opioid products are can be manipulated for non-oral abuse; therefore, most abuse-deterrent technologies make it more difficult or make abuse of the manipulated product less appealing for non-oral abuse, the article explained. For example, reformulated oxycodone (OxyContin) was the first FDA-approved abuse-deterrent opioid formulation, which used physical and chemical properties that make it difficult to crush the tablet.

The authors also discussed Embeda, approved in 2014, which consists of pellets of morphine sulfate, each containing a core of sequestered naltrexone that is intended to remain sequestered when the product is taken as prescribed. Naltrexone is released and exerts opioid antagonism if the tablet is crushed and potentially causes symptoms of withdrawal, according to the authors.

“One strategy of abuse deterrence incorporates aversion properties into a formulation; components are added to the opioid formulation that produces an unpleasant effect if manipulated (eg, mucous membrane irritant for intranasal abuse). The unique delivery system strategy uses long-acting injectable or depot formulations that are difficult to manipulate,” the authors stated. “The use of a prodrug as an opioid ADF would require a chemical or enzymatic conversion to active drug.”

The report emphasized that patient education on the risks of abuse and diversion is important and necessary. Additionally, ADFs require the cooperation of all stakeholders. Specifically, physician assistants and nurse practitioners play a significant role in providing necessary care and battling opioid misuse, the authors wrote.

Reference

Adler JA, Mallick-Searle T. An overview of abuse-deterrent opioids and recommendations for practical patient care. [published onlune Jul 11, 2018]. J Multidiscip Healthc. doi: 10.2147/JMDH.S166915.