Abuse-Deterrent Formulations in the Treatment of Chronic Pain

Abstract

Prescription drug abuse is the fastest growing problem in the United States. According to the Centers for Disease Control and Prevention (CDC), enough opioid pain relievers were sold in 2010 to provide every adult in the United States with the equivalent of a typical dose of 5 mg of hydrocodone every 4 hours for 1 month. Many solutions have been proposed to address this problem, including treatment guidelines, political solutions (statutory changes), Risk Evaluation and Mitigation Strategy (REMS), and technological innovations. Many opioid products are manipulated (crushed, snorted, injected, etc.) to facilitate abuse. Since extended-release/long-acting (ER/LA) opioids contain a large amount of opioid contained in a single delivery system, they are a favorite target of abusers. In short, the goal of an abuser is to convert an ER/LA opioid into an immediate-release one. Abuse-deterrent formulations (ADFs) are intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding. One such technological solution is the development of ADFs for opioid pain medications. The Food and Drug Administration's (FDA) guidelines for industry released in 2015 establish the rationale and methodology for the development of ER/LA opioids that contain abuse-deterrent properties. The goal is to deter abuse, realizing that it is impossible to prevent abuse. Key words: abuse-deterrent formulations, abuse-deterrent opioids, CDC guidelines, FDA opioid guidelines, opioid abuse, opioid deaths, opioid diversion, opioid overdose, prescription drug abuse, REMS