Faculty Articles

Title

Safety and performance of current abuse-deterrent formulations.

ISBN or ISSN

1744-7607

Publication Title

Expert Opinion on Drug Metabolism and Toxicology

Volume

14

Issue

12

Publication Date / Copyright Date

12-1-2018

First Page

1255

Last Page

1271

Publisher

Informa Healthcare

DOI Number

10.1080/17425255.2018.1546289

Abstract

INTRODUCTION: Prescription opioid abuse is now an epidemic that has forced the government and industries to take initiatives. These include developing abuse-deterrent formulations (ADFs), issuing regulatory guidances and allocating massive budgets to ensure the safety and effectiveness of these medications. Areas covered: This review covers the regulatory guidance on evaluation and labeling of the branded and generic ADFs. It also includes the relevant patents and technologies, the in-vitro, in-vivo, the post-marketing data, the FDA reviews, and the products' labeling of the FDA-approved products with abuse-deterrent features. Expert opinion: Despite the development of a dozen products with abuse-deterrent features, most of these technologies rely on the same deterrent agent, making it easier for abusers to focus their manipulation efforts and share their experience to defeat the technology. Further advancement in the field requires developing more robust, more diverse, safer, and affordable deterrent technologies for the extended- and immediate-release opioid products. Moreover, advances in the reporting of the post-market results, issuance of policies in support of the ADFs, and concurrent monitoring of the illicit opioid market are other considerations that can further help in confronting the epidemic.

Disciplines

Medicine and Health Sciences | Pharmacy and Pharmaceutical Sciences

Keywords

Abuse-Deterrent Formulations, Analgesics, Opioid, Drug Design, Drug Labeling, Humans, Opioid-Related Disorders, Substance-Related Disorders, United States, United States Food and Drug Administration

Peer Reviewed

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