NCHR Testimony at the Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

Megan Polanin, PhD, April 5, 2017

Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a licensed clinical psychologist in Washington D.C. and a Senior Fellow at the National Center for Health Research. I previously trained at Johns Hopkins University School of Medicine. 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, and 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 the creation of opioid analgesics that deter abuse. 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.” According to the FDA materials provided, it appears that RoxyBond is more abuse-deterrent compared with Roxicodone. However, there is still abuse potential for the intranasal and intravenous use of RoxyBond.

The studies about RoxyBond’s abuse are limited. In the laboratory setting, it appears to meet the FDA’s current standards for “abuse-deterrent.” Whether its abuse-deterrent properties are effective in the real world and whether Roxybond is a “better” drug are much more difficult questions that will require postmarketing data. We know from previous experience with opioids that the FDA has designated as abuse-deterrent that once this drug is on the market, it may be abused more widely than current laboratory studies suggest. That is exactly what happened with reformulated Opana ER, as several members of this panel are aware.

Compared with the FDA-approved extended-release/long-acting abuse-deterrent opioids, RoxyBond’s characteristics are similar regarding “drug liking” and “taking the drug again.” Thus, it does not appear more likely to be abused than extended-release/long-acting opioids.

Unfortunately, this comparison is rudimentary and less than ideal for several reasons. First, a direct comparison is impossible given a lack of sufficient information. Second, we are utilizing extended-release/long-acting opioids currently on the market as a comparison, which does not set a high standard.

The FDA’s guidelines state that a drug’s label should reflect and describe a product’s specific abuse-deterrent properties, such as an abuser’s ability to crush a tablet and extract the opioid. Thus, RoxyBond’s label should include its specific abuse-deterrent properties and clearly specify the potential risks of intranasal and intravenous abuse. Most important, the FDA should require opioids to have a black box warning indicating that, although the drug may be more difficult to crush or inject, it is still highly addictive.

Opioid addiction is an epidemic in the U.S. and labeling a drug as abuse-deterrent influences doctors, patients, and family members. 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 be diligent in analyzing whether this drug’s abuse-deterrent properties result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes compared with Roxicodone once it is marketed to consumers. Although current data suggest that this drug will be less likely to be abused, abusers of the drug can be more creative or implement unique techniques to overcome those deterrents. Thus, sufficient follow-up is critical in order to determine if this is actually the case.

If approved with abuse-deterrent labeling, this will be the first immediate-release abuse-deterrent opioid, and it will likely be favored for prescriptions and will set a standard for future drugs to meet. Thus, it is important for this panel and the FDA to make approval decisions based on good science and strong data.

To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high and truthful standard. We urge this Advisory Committee to advocate for patient safety by demanding that the FDA include labeling regarding RoxyBond’s specific abuse-deterrent properties as well as the specific routes of abuse that the product has been developed to deter. We also urge this Committee to recommend that, if RoxyBond is approved, postmarket studies should be required immediately to evaluate its use and abuse once it is on the market.