NCHR Testimony at FDA on Opioid, Opana ER

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 high public health priority. Although the reformulated Opana ER was designed to prevent abuse by making it more difficult to abuse via intranasal or injection routes, the reality is very different. Compared with other opioids, reformulated Opana ER, along with its generic counterpart, had the highest injection abuse rates following reformulation.

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.” Instead of lowering the risk of abuse, however, the reformulation of Opana ER seems to have resulted in significantly increased rates of abuse via injection.

The term “abuse-deterrent” is not accurate for reformulated Opana ER because the drug is widely abused. 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. Despite the drug’s incorporation of physiochemical properties aimed at making it more difficult to abuse by intransal or injection routes, it is misleading to doctors, patients, and family members to say or imply that the drug is more difficult to abuse. In fact, the drug’s black box warning should be amended to more clearly specify the risks of injection abuse.

Compared to other types of opioid abuse, the injection of opioids is associated with increased infection risk. This risk is even greater because of Opana ER’s high potency and short duration, which results in more injections per day. In addition, the high cost of this drug can lead to equipment sharing. Individuals who injected the reformulated version have been especially likely to develop thrombotic microangiopathy (TMA). Abuse by injecting “melted” tablets resulted in an HIV outbreak in Scott County, Indiana. This drug is not only failing to deter abuse, but it is generating additional public health problems.

Opioid addiction is an epidemic in the U.S. and labeling a drug as abuse-deterrent which is actually widely abused would greatly contribute to the problem, by misleading doctors, patients, and family members.

To be part of the solution rather than part of the problem, the FDA should be more specific and accurate when claiming that a drug is abuse-deterrent. Research indicates that many physicians believe that a drug labeled “abuse deterrent” is less addictive. If a drug is crush-resistant, or difficult to crush in a specific way, it should be labeled as crush-resistant, not as abuse-deterrent. Only those drugs that significantly reduce the chances of abuse should be labeled as abuse-deterrent, and the reasons for that label should be clearly explained.

We strongly agree with the FDA’s 2013 denial of Endo Pharmaceuticals’ citizen petition to label Opana ER as abuse-deterrent, and we strongly urge the Advisory Committee to recommend that the FDA continue to deny this company’s requests to include abuse-deterrent labeling. To reduce the epidemic, the FDA must hold pharmaceutical companies to a truthful standard: Only abuse-deterrent drugs should have that label.

We also agree with the FDA’s 2013 denial of Endo Pharmaceuticals’ requests to take the original Opana ER off the market. This company has not proven that the original Opana ER poses an increased potential for abuse compared with reformulated Opana ER. We urge the FDA to continue to deny Endo’s request to withdraw the original Opana ER from the market for safety and effectiveness reasons.

We urge this Advisory Committee to advocate for patient safety by rejecting the companies’ requests and instead demanding that reformulated Opana ER have a stronger, more specific black box warning.

The joint Advisory Committee, composed of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committees, voted on this question: “Do the benefits of reformulated Opana ER continue to outweigh its risks?” The Committee voted 18-8, with 1 abstention, that the benefits of this drug do not outweigh its risks. Read more about the meeting here.