FDA Releases Final Guidance On Abuse-Deterrent Opioids
The FDA has released its finalized industry guidance for the development of abuse-deterring opioid drugs.
The guidance details the type of studies that should be conducted to demonstrate abuse-deterrent properties, as well as how those studies should be evaluated, and the labeling of these drugs based on study results.
It are intended to assist drug makers hoping to develop abuse-deterring opioid drugs, support advancements in this area of study, and make the regulatory process as easy as possible. While it do not address generic drugs, draft guidance on the development of generic options is currently being written.
“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,” they wrote.
“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 full guidelines are available on the FDA’s website.
FDA. FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm440713.htm. Accessed April 2, 2015.