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.

KEYWORDS:

• Abuse-deterrent
• formulations
• labeling
• opioids
• US Food and Drug Administration

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Acknowledgments

The authors would like to thank Anne Z DePriest, PharmD, BCPS, of Janssen Scientific Affairs, LLC, for her valuable contributions to the initial outline and early drafts of this review manuscript.

Declaration of interest

LR. Webster is an employee of PRA Health Sciences and has received honoraria for acting as a consultant for: Cara Therapeutics, Egalet Corporation, Elysium, Kaleo Pharmaceuticals, Kempharm Inc, Mallinckrodt Pharmaceuticals, Pain Therapeutics Inc, Pfizer, and Teva. He has received honoraria for roles on the advisory boards for Egalet Corporation, Jazz Pharmaceuticals, Silex Pharmaceuticals, Shionogi Inc, Teva, and Trevena Inc; and has received travel expenses from AstraZeneca, Cara Therapeutics, Depomed Inc, Egalet Corporation, Elysium, Kaleo Pharmaceuticals, Kempharm Inc, Pfizer, Shionogi Inc, Teva, and Trevena Inc. J Markman has participated in advisory boards or in a consulting role for the following firms: Allergan, Aptinyx Inc, Biogen, Chromocell Corporation, Collegium Pharmaceutical Inc, Convergence Pharmaceuticals, Daiichi, Egalet Corporation, Endo Pharmaceuticals Inc, Immune Pharmaceuticals, Kempharm Inc, Nektar Therapeutics, Novartis, Pfizer, Purdue, Quark Pharmaceuticals, Sankyo, and Teva. He has received research support from Depomed Inc, New York State, and Pfizer. EJ. Cone is an employee of PinneyAssociates and provides consulting services, including the design and interpretation of Category 1 studies, to Egalet Corporation and other developers of CNS medications. G Niebler is an employee of Egalet Corporation and may own Egalet stock or stock options.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance, provided by Mariana Ovnic, PhD, and Patrick Little, PhD, of Complete Publication Solutions, a CHC Group company (North Wales, PA), was utilized in the production of this article and funded by Egalet Corporation (Wayne, PA).

Additional information

Funding

This paper was funded by Egalet Corporation (Wayne, PA).