The FDA recently requested that Endo Pharmaceuticals remove its Opana ER pain medication from the market because of the risk for addiction. An already nervous nation of people who rely on opioids to treat pain, and the health professionals that prescribe them, has its eyes on what may become a slippery slope. The Agency’s request to voluntarily remove Opana ER, was a first-of-its-kind by the regulatory body. Now patients and providers are asking, what’s next?
The Agency is also reportedly looking at two other generic opioids – oxymorphone extended release and oxymorphone immediate release – stating that the agency “is currently assessing the latest available data on abuse patterns” for the two drugs, according to FDA spokeswoman Sarah Peddicord.
FDA Commissioner Scott Gottleib, MD issued an announcement stating that the agency is taking new steps to “help assess opioid drugs with abuse-deterrent properties.”
Here is the announcement in its entirety.
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.
The FDA is committed to looking at all facets of this complex issue and collaborating on various approaches, as there are no simple answers to reverse this epidemic. In my prior communication, I noted that one of these approaches would be asking the public, through various forums, to share additional steps and information that the FDA should consider in addressing these challenges. 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?
These products – opioid formulations with properties designed to deter abuse – are each intended to deter abuse by particular routes (like snorting or injecting), depending on the drug. For example, some make crushing or manipulating the tablet to dissolve in liquid for injection more challenging; others combine the active opioid analgesic ingredient with drugs such as naloxone, which if snorted or injected will block the high of the opioid. This has been an important area of innovation that the FDA continues to support. 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.
To address this need, after approval, we have required companies marketing these products to conduct studies in a way that will provide the most meaningful data possible to address this issue. But these studies are challenging to conduct, and we need the most reliable data we can get to make the best regulatory decisions. Therefore, we are taking steps to get the answers we need to inform our approach.
At the meeting, which will be held July 10-11, we will engage external thought leaders in a discussion about how we can better leverage existing data sources and methods to evaluate the impact of these products in the real world, as well as what new data sources and study designs could be developed or enhanced to ensure these efforts result in the best possible answers to inform regulatory decision-making. To make this discussion as productive as possible, we have made public an issues paper outlining some of the existing regulatory and public health challenges we face.
Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction. Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”