FDA to Reevaluate Abuse-Deterrent Opioid Efficacy

After labeling America’s opioid addiction crisis as the FDA’s “greatest immediate challenge,” Commissioner Scott Gottlieb announced that the FDA will begin to scrutinize the efficacy of abuse deterrent opioid formulations currently on the market.

“Today, we are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic,” Dr Gottlieb asked in a press release. “However, we recognize that there is a gap in our understanding of whether these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse.”

The FDA will convene for a two-day workshop in order to examine how abuse-deterrent formulations are impacting the opioid misuse epidemic. There are currently 10 abuse-deterrent formulations on the market in the United States. According to the FDA, each formulation contains some sort of deterrent property, such as making the product more difficult to crush or snort, while other formulations include naloxone, an agent that blocks the “high” associated with misuse.

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However, recent studies have determine that these products have barriers to efficacy. In a recent JAMA Psychiatry study, Theodore J Cicero, PhD^, Matthew S Ellis, MPE, both of the department of psychiatry at Washington University in St Louis, Missouri, noted that while abuse deterrent formulations can achieve their desired impact, they often lead to residual forms of abuse. According to the study, patients who were switched to abuse deterrent formulations often transitioned from nonoral misuse to oral misuse or defeated the deterrent mechanism.

Another barrier to uptake of abuse deterrent opioids is high cost. At the AMCP 2017 Annual Meeting, Tyson Thompson, PharmD, clinical consultant pharmacist at UMass Medical School, explained that the role of abuse deterrent formulations in addiction management plans is limited.

“Right now, the barrier to widespread adoption of abuse deterrent formulations is obviously cost,” Dr Thompson said during his presentation. “If you are trying to contain cost, [abuse deterrent formulations] could be a little too much for you.”

Dr Thomspon also pointed to the need for post-marketing data in order to better understand abuse deterrent opioid formulations.

“Probably the biggest question that needs to be answered, as to whether or not they are going to have the effect that we intend them to have, is when we see post-marketing data that shows that they’ve clearly reduced abuse in the community,” he said. “Because as it stands, right now most [abuse deterrent formulations] only have clinical abuse potential studies with 50-some odd recreational opioid users, but we just don’t have that community evidence yet.”

In an issue paper released by the FDA, the Agency stressed that understanding post-marketing data is key to improving abuse-deterrent formulations.

“Evaluating the effects of opioid formulations designed to deter abuse in post-approval settings is important for understanding the impact of these products on abuse after approval, but this is a new area of inquiry, so standard approaches and methodologies are still being developed,” the FDA wrote. “The current approaches to these studies are challenging on many levels, and we seek to bring together scientific expertise to help illuminate ways to improve the data sources and the methodologies.”

—David Costill