• Ronald S Litman, Olivia H Pagán, and Theodore J Cicero.
• From the Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, Institute for Safe Medication Practices, Horsham, Pennsylvania, and the Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee, Silver Spring, Massachusetts (R.S.L.); Drexel University, Philadelphia, Pennsylvania (O.H.P.); and the Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri (T.J.C.).
• Anesthesiology. 2018 May 1; 128 (5): 1015-1026.

AbstractAbuse-deterrent opioid formulations have been suggested as one way to decrease the abuse, addiction, and overdose of orally prescribed opioids. Ten oral opioid formulations have received abuse-deterrent labeling by the U.S. Food and Drug Administration (FDA). Their properties consist of physical and/or chemical means by which the pills resist manipulation and create a barrier to unintended administration, such as chewing, nasal snorting, smoking, and intravenous injection. In this review, we describe the mechanisms of abuse-deterrent technology, the types of premarketing studies required for FDA approval, the pharmacology of the currently approved abuse-deterrent opioid formulations, and the evidence for and against their influence on opioid abuse. We conclude that there is currently insufficient evidence to indicate that the availability of abuse-deterrent opioid formulations has altered the trajectory of opioid overdose and addiction; however, postmarketing studies are in their infancy, and novel deterrent formulations are continually being developed and submitted for marketing approval.

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