title: Current and future development of extended-release, abuse-deterrent opioid formulations in the United States.
abstract: Prescription opioid misuse and abuse in the United States (US) is epidemic and is a major burden on health-care resources and costs to society. The need to significantly reduce the risks of prescription opioid misuse and abuse must be balanced with the important needs of patients with chronic pain who may benefit from treatment with opioids. The use of abuse-deterrent formulations (ADFs) of prescription opioids is one approach that could reduce the risk of prescription opioid abuse and misuse while maintaining access to opioids. ADF opioids have properties that make their abuse more difficult, less attractive, or less rewarding. In 2015, the US Food and Drug Administration issued final guidance to industry for the development of ADF opioids that recommended specific studies be conducted to demonstrate the abuse-deterrent properties of new opioid formulations. The technologies and the preclinical and clinical development of ADF opioids are rapidly evolving. This review provides an overview of the required testing for product labeling that includes language about the abuse-deterrent features of an ADF opioid. The objective of this review is to inform and help health-care providers understand the unique development of extended-release ADF opioids and their place in the treatment of patients with pain.
authors.affiliation: a Scientific Affairs , PRA Health Sciences , Salt Lake City , UT , USA.
authors.forename: Lynn R
authors.initials: LR
authors.lastname: Webster
authors.affiliation: b Department of Neurosurgery , University of Rochester Medical Center , Rochester , NY , USA.
authors.forename: John
authors.initials: J
authors.lastname: Markman
authors.affiliation: c PinneyAssociates , Bethesda , MD , USA.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Cone
authors.affiliation: d Clinical Development and Medical Affairs , Egalet Corporation , Wayne , PA , USA.
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: Niebler
mesh_terms: D000701:Analgesics, Opioid / Q000592:standards* / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D017408:Guidelines as Topic; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D055553:Prescription Drugs / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D055553:Prescription Drugs
keywords: Abuse-deterrent; US Food and Drug Administration; formulations; labeling; opioids