FDA: Industry should focus on abuse-deterrent opioids

The FDA recently issued a draft guidance document to encourage drug manufacturers to develop new formulations of opioid drugs with abuse-deterrent properties.

“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,” Margaret A. Hamburg, MD, commissioner of the FDA, said in a press release. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.”

Margaret A. Hamburg

The document, “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” lays out the FDA’s current thinking about the type of studies that should be conducted to test the safety and efficacy of abuse-deterrent opioids, how the FDA will evaluate those studies, and what labeling claims can be approved based on study results.

The science of abuse deterrence is a relatively new area of research, according to the FDA, and it will take a flexible approach to evaluate and label these new products.

“While prescription opioids are an important component of pain management, abuse and misuses of these products have resulted in too many injuries and deaths across the United States,” Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said in the press release. “An important step toward the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”

The new draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy’s Prescription Drug Abuse Prevention Plan.

“Our nation is in the midst of a prescription drug abuse epidemic,” Gil Kerlikowske, director of the Office of National Drug Control Policy, said in the press release. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic. This guidance is a vital component of the administration’s comprehensive effort to reduce prescription drug abuse in America, and we commend the FDA for its commitment to this challenge.”

The FDA will be open to public comment on the draft guidance for 60 days. Instructions for public comment will be announced in an upcoming Federal Register notice.