Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from the drug or medical device industry, so I have no conflicts of interest.
The development of opioids formulated to prevent abuse is a public health priority, and we support the FDA’s efforts to encourage their development. The FDA states that a product that has abuse-deterrent properties means that “the risk of abuse is lower than it would be without such properties.”
The in vitro testing demonstrates that, compared with reformulated Oxycontin ER, IPC Oxy displayed similar and, in some cases, superior abuse-deterrent properties. For example, IPC Oxy was more difficult to get into a syringe for typical “recipes” used to abuse reformulated Oxycontin ER. However, please keep in mind that comparison to a so-called abuse-deterrent opioid currently on the market does not necessarily set a high standard.
The FDA states that “the development of an abuse-deterrent opioid product should be guided by the need to reduce the abuse known or expected to occur with similar products.” Based on this criterion, the results of in vitro testing provide promising evidence that IPC Oxy provides incremental improvement to deter intravenous abuse over reformulated Oxycontin ER. However, with no data from pharmacokinetic and clinical abuse potential studies, it is difficult to make assumptions about IPC Oxy’s effects in the real world.
Proving whether IPC Oxy’s abuse-deterrent properties are effective in the real world will require data from Categories 2 and 3 studies. For example, as mentioned during discussion today, the blue dye intended to deter abuse could be novel or intriguing for teenagers. It is also unclear from the available evidence how much is known about whether this ADF could have unexpected health effects when used long term or abused.
We know from previous experience that once opioids designed to be abuse-deterrent are on the market, they tend to be abused more extensively than laboratory studies suggest. That is exactly what happened with reformulated Opana ER, which FDA recently decided should be taken off the market. Although available data suggest that this drug will be less likely to be abused intravenously, individuals who are addicted are highly motivated to overcome those deterrents.
Opioid addiction is an epidemic in the U.S. and labeling a drug as abuse-deterrent influences doctors, patients, and family members. We commend the FDA for making it a priority to find ways to adequately explain risks in the label, including distinguishing between the risk of abuse and the risk of addiction. At the FDA’s recent Public Workshop on opioids, Commissioner Gottlieb said, “…we don’t want to improperly convey a perception that a product that is resistant to manipulation and abuse is somehow also less prone to fueling addiction, when that is simply not true.” We strongly agree with Commissioner Gottlieb’s statement. Unfortunately, many doctors think abuse-deterrent means an opioid is less addictive.
To be part of the solution rather than part of the problem, the FDA should require sufficient evidence that this drug’s abuse-deterrent properties result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes. The two FDA-approved abuse-deterrent single ingredient oxycodone opioids included pharmacokinetic and clinical abuse potential studies before receiving the abuse-deterrent designation. The FDA should not use a lower standard for approval for IPC Oxy as abuse-deterrent.
It is important for this panel and the FDA to make approval decisions based on good science and strong data. Do the current data represent “rigorous evaluation” of IPC Oxy’s impact? Do we know enough to determine the real-world impact of this opioid formulation intended to be abuse-deterrent?
To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high standard with clear evidence. We do not believe IPC Oxy should be designated as abuse-deterrent unless that is clearly proven as we are concerned about unexpected impacts of the formulation without pharmacokinetic and clinical abuse potential studies. We urge the Committee to vote that there is not sufficient data for this product to support inclusion of language regarding abuse-deterrent properties in the product label for the IV route of administration.
In order to be labeled as abuse-deterrent, we urge you to recommend that data from Categories 2 and 3 studies be required to provide evidence that IPC Oxy is abuse-deterrent. If there is a reason that this data is not necessary, there needs to be sufficient justification so that a lower standard is not set for approvals of future abuse-deterrent formulations.
Thank you for the opportunity to share our perspective.
The joint Advisory Committee, composed of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committees, voted 22-1 against approval of the abuse-deterrent formulation of extended-release oxycodone hydrochloride. Committee members voted 19-4 that the pharmaceutical company had not demonstrated that the drug could be expected to deter abuse for the IV route of administration and 23-0 that the product should not include information on the label about its abuse-deterrent properties for the IV route of administration. Read more about the meeting here.