What’s holding back abuse-deterrent opioid formulations? Considering 12 U.S. stakeholders

ABSTRACT

Introduction: There is no greater public health threat at this time in America than the opioid abuse crisis, and a systematic, level-headed, coherent, and unified approach is needed. Among the many things that have been proposed to help reduce opioid abuse is the development of opioid analgesic products in abuse-deterrent formulations (ADFs). This seems to make perfect sense.

Areas covered: In this article, the viewpoints of 12 stakeholders (physicians, pain patients, payers, manufacturers, regulators, law enforcement, hospitals, first responders, elected officials, rehabilitation centers, opioid addicts, and the general public) were considered in terms of how ADF opioids are regarded and might contribute potential impediments to more widespread use. This is a narrative review based on the literature. Stakeholders were not surveyed directly.

Expert opinion: Although abuse-deterrent technology for opioid analgesics has been available for several years, ADFs have not gained widespread acceptance. ADF products serve an important but limited purpose, but their incremental costs may serve as a ‘mixed message’ for many of the stakeholders concerned about cost containment.

KEYWORDS:

• Abuse-deterrent formulation
• abuse-deterrent opioid
• opioid epidemic

Article highlights

• Abuse-deterrent formulations (ADF) of opioids are currently endorsed by the FDA and several have approved ADF labeling (and others have abuse-deterrent features but lack the ADF labeling). Not all opioids, however, are available in an ADF.

• The majority of opioids prescribed and dispensed in America are conventional (non-ADF) products, yet ADF opioids comprise a substantial revenue stream for their manufacturers. The incremental costs for these new, branded ADF products has caused payers, including even the Centers for Medicare and Medicaid Services (CMS) to fail to embrace them.

• Strong evidence is not yet present to support the use of ADF products, although they make intuitive good sense. It is not known, for example, if the entrance of an ADF opioid to the market will cause opioid abusers to migrate to a different product or even heroin.

• National legislation is pending that would mandate all new opioids come to market as an ADF; the Food and Drug Administration (FDA) had once discussed that option but continues to approve new opioids without an ADF.

• While one can advance an argument that ADF opioids may be effective in reducing abuse, even in theory, they cannot prevent all abuse. ADF products aim at thwarting manipulation or tampering, so that the opioid can be extracted by abusers who want to inhale, smoke, or inject it. ADF opioids can be misused or abused by taking them intact.

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. The authors of this paper were assisted with manuscript submission only, by John Bisney, LeQ Medical. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.