Assessing the impact of abuse-deterrent opioids (ADOs): identifying epidemiologic factors related to new entrants with low population exposure

ABSTRACT

Objective: Prescription opioid misuse and abuse is a serious public health concern that can lead to overdose, addiction, and death. The development of opioid formulations designed to deter misuse and abuse is considered an important step towards addressing the problem, but the extent to which abuse-deterrent opioids (ADOs) actually deter abuse in the community requires confirmation through epidemiologic studies. Epidemiologic evaluations of misuse and abuse present several unique challenges related to study design, sources of data, and methodology, particularly for new entrant ADOs with low population exposure. The purpose of this article is to review the critical methodologic issues that must be considered when designing an epidemiologic evaluation of prescription opioid misuse and abuse, and deterrence for new entrant ADOs.

Methods: A systematic feasibility assessment was conducted by critically evaluating and applying epidemiologic principles to combinations of epidemiology study design, study directionality, population, data source, clinical and patient-reported endpoints, type of comparator, effect size, and the ability to control for confounding variables.

Results: Ten epidemiologic factors were identified that are considered key to an epidemiologic evaluation, and the issues associated with each are summarized.

Conclusion: Given the low population exposure of new entrant ADOs, there is limited feasibility in conducting the epidemiologic studies necessary to evaluate the effectiveness of these products in deterring abuse. Clear regulatory guidance is needed.

KEYWORDS:

• Abuse-deterrent opioids
• epidemiology
• methodology
• opioids
• prescription opioid abuse
• prescription opioid misuse

Acknowledgments

Portions of this manuscript were included as part of a presentation by David A Brown entitled ‘King’s Proposed Epidemiology Approach to Assess Abuse Deterrence of EMBEDA’ to a Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) held in Gaithersburg, MD on October 21-22, 2010 (FDA Archive).

Declaration of interest

Writing support was provided by David Lickorish, PhD, and Diane Hoffman, PhD, of Engage Scientific Solutions and was funded by Pfizer. C Roland, B Setnik, and D Brown were employees of King Pharmaceuticals (acquired by Pfizer in 2011) at the time this assessment was conducted. C Roland is a full-time employee of Pfizer and holds stock and/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.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This assessment was funded by King Pharmaceuticals, Inc. (Bridgewater, NJ), which was acquired by Pfizer Inc in March 2011.