The Food and Drug Administration (FDA) on Wednesday issued a final guidance to help the industry develop opioid drug products with potentially abuse-deterrent properties.
FDA officials say opioids are very beneficial when used properly, but also carry the risk of abuse, misuse and death. The FDA sees its publication, “Guidance for Industry: Abuse-Deterrent Opioid,” as an important step toward balancing the suitable access to opioids for patients with reducing the risks of abuse.
“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” FDA Commissioner Margaret Hamburg said. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”
The document explains the FDA’s current position on the studies that should be conducted to show that a given formulation has abuse-deterrent properties. The document also makes suggestions on how studies should be performed and evaluated, as well as discussing what labeling claims may be approved based on results.
“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said.