FDA Issues Guidelines for Drug Industry on Developing Abuse-Deterrent Opioids

The Food and Drug Administration (FDA) this week issued guidelines for drug manufacturers on developing opioid painkillers that are more difficult to abuse. The guidelines recommend the types of studies needed to prove drugs can deter abuse, The Wall Street Journal reports.

The FDA guidelines also make recommendations about how these studies should be performed and evaluated. They discuss what labeling claims may be approved based on the results of those studies, according to an agency news release.

The FDA said it hopes to encourage drug makers to develop opioids that are more difficult to crush, inject or snort to produce a more intense high. The agency noted even abuse-deterrent formulations are not “abuse-proof.”

“We hope that this guidance is going to provide an incentive for real abuse-deterrent products,” said Dr. Douglas Throckmorton, Deputy Director of Regulatory Programs at the FDA’s Center for Drug Evaluation. “We hope the industry will find that this guidance lays out a road map” for how to develop abuse-deterrent painkillers that will gain FDA approvals, he told the newspaper.

About 30 drug makers have been in recent discussions with the FDA about making abuse-deterrent formulations, the agency said.

Dr. Andrew Kolodny, President of Physicians for Responsible Opioid Prescribing, recommended other steps the FDA could take to reduce opioid abuse. These include taking larger dosages off the market, and prohibiting marketing of powerful opioids for certain conditions, such as low back pain.