FDA Workshop on Abuse Deterrent Opioids: Distinguishing Products in Postmarketing Surveillance to Support Category 4 Labeling

Categories: Abuse Deterrent, FDA, Opioids, Postmarketing Surveillance

Understanding the real-world effectiveness and value of abuse-deterrent opioids depends on surveillance designed to evaluate how these formulations work in the real world, product by product, and distinguishing prescription opioids from illicitly produced street products, such as counterfeit synthetics.

Drs. Sid Schnoll and Jack Henningfield both reinforced this message in a public workshop organized by the FDA in July on “Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities”. Dr. Schnoll participated as an invited member of the workshop panel, and Dr. Henningfield presented during the public comment period.

Prescribing and market share of abuse deterrent opioids is very small compared to non-abuse deterrent opioids, largely because of pricing. That makes tracking their impact particularly challenging for surveillance. Abuse-deterrent formulation of opioids constitute one piece of the puzzle to addressing the overall public health goals of preventing and reducing opioid abuse, addiction, and overdose in America. Their effectiveness and value to comprehensive opioid control efforts must be evaluated by measures that are appropriate to what these formulations are designed to do.

“Going forward we need to be careful to distinguish surveillance designed to evaluate how well AD opioids are working to achieve the goals that they are designed to do, product by product, such as reduction of insufflation and injection, rather than stopping the overall abuse of opioids,” said Dr. Schnoll.

Part of the challenge for surveillance is actually relating specific products and substances with abuse and overdose. Most overdose deaths involve the ingestion of several substances yet the headlines often refer to whatever drug happens to be in the media spotlight at the time or confuse illicitly made and distributed synthetics such as fentanyl and analogs with prescription drugs. Similarly, most prescription drug abuse and overdose occurs in people who did not have prescriptions yet are discussed as though they were prescribed pain patients – a population that overall shows very low rates of abuse and overdose.

FDA has yet to describe the requirements for Category 4 labeling, meaning that sponsors have the opportunity to propose study designs. PA experts design and execute postmarketing surveillance for a range of controlled substances, including abuse-deterrent formulations of opioids. Our experts can design prospective or retrospective cohort studies and integrate epidemiology and other data with the cohort study results.