title: Abuse-deterrent formulations of prescription opioid analgesics in the management of chronic noncancer pain.
abstract: Misuse, abuse and diversion of prescription opioid analgesics represent a global public health concern. The development of abuse-deterrent formulations (ADFs) of prescription opioid analgesics is an important step toward reducing abuse and diversion of these medications, as well as potentially limiting medical consequences when misused or administered in error. ADFs aim to hinder extraction of the active ingredient, prevent administration through alternative routes and/or make abuse of the manipulated product less attractive, less rewarding or aversive. However, opioid ADFs may still be abused via the intended route of administration by increasing the dose and/or dosing frequency. The science of abuse deterrence and the regulatory landscape are still relatively new and evolving. This paper reviews the current status of opioid ADFs, with particular focus on different approaches that can be used to deter abuse, regulatory considerations and implications for clinical management.
authors.affiliation: Gold Coast Research, LLC, Plantation, FL, USA.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Hale
authors.affiliation: CIMA Labs Inc., Brooklyn Park, MN, USA.
authors.forename: Derek
authors.initials: D
authors.lastname: Moe
authors.affiliation: TEVA Pharmaceuticals, Frazer, PA, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Bond
authors.affiliation: TEVA Pharmaceuticals, Frazer, PA, USA.
authors.forename: Maciej
authors.initials: M
authors.lastname: Gasior
authors.affiliation: TEVA Pharmaceuticals, Frazer, PA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Malamut
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D059350:Chronic Pain / Q000188:drug therapy*; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D063487:Prescription Drug Misuse / Q000517:prevention & control*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid
keywords: abuse; abuse deterrence; abuse-deterrent formulations; chronic noncancer pain; diversion; manipulation; prescription opioid analgesics