Nina Zeldes, PhD, National Center for Health Research, January 15, 2020
Thank you for the opportunity to speak here today. My name is Dr. Nina Zeldes and I am here speaking on behalf of the National Center for Health Research, where I am a Senior Fellow. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
While opioids can help patients suffering from pain, as we all know too well, they can also cause tremendous harm. The opioid epidemic stems from inappropriate prescriptions; false and misleading marketing; insufficient oversight and regulatory control; inadequate risk mitigation; and insufficient public health and social services infrastructures.
Our Center strongly supports research and programs to improve the safety and appropriate use of opioids. All drugs that the FDA evaluates should be held to a high standard for approval, but the standard for opioids needs to be even higher because the known risks of addiction are so high, even when the drugs are taken as directed.
Unfortunately, the term “abuse-deterrent” has contributed to the opioid epidemic. Research shows that doctors, patients, and family members have misunderstood the term, thinking it meant “less addictive.” Instead, abuse-deterrent has various meanings, such as crush-resistant, difficult to inject, or something else that made the drug harder – but definitely not impossible — to abuse. In some cases, the drug was difficult to abuse in some ways but easier in other ways.
And most important, the research that the FDA presented at the Advisory Committee meeting on Tuesday and today shows that the misuse and abuse of opioids is often from patients taking more pills than they are supposed to take. Snorting, injecting, and other means of abuse of opioids are not the most common way they are abused.
With that knowledge, the FDA needs to re-think its use of the term “abuse-deterrent” and it certainly should not apply to this drug, since there is no evidence that it would be significantly less likely to be abused than most other opioids.
This drug [Aximris] may deter abuse by the IV route to some degree. Unfortunately, individuals who are addicted are highly motivated to overcome those deterrents. At the same time, this new formulation does not deter nasal and oral abuse. In fact, the intranasal abuse potential appears to be higher compared to oxycodone IR tablets.
We know from previous experience that so-called abuse-deterrent opioids are sometimes abused more widely than current laboratory studies suggest. As the FDA pointed out, Opana is one example.
Therefore, FDA should require sufficient evidence that this drug’s abuse-deterrent properties will result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes. If so, it should be labeled as crush-resistant or whatever term is an accurate description of its properties, but not abuse-deterrent, since that term is widely misunderstood.
This formulation should not be approved. And if FDA in the future labels drugs as difficult to inject, FDA should also require a black box warning indicating that, although the drug may have properties that make it more difficult to inject or snort, it is still highly addictive in whatever way it is consumed.
Thank you for the opportunity to share our perspective, which is based on analyzing data from the FDA’s own reports as well as published sources and interviews with patients and physicians.
The Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 24 to 2 against approval of the extended release opioid Aximris.