FDA: Draft guidance issued on abuse-deterrent opioids

FDA: draft guidance issued on abuse-deterrent opioids
The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.

(HealthDay)—The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.

The document entitled "Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling," details the FDA's current thinking about the studies that should be done to demonstrate abuse-deterrent properties in a given formulation, how those studies will be evaluated by the FDA, and what labeling claims may be approved based on the study results.

This draft guidance fulfills mandates under the Safety and Innovation Act and the Office of National Drug Control Policy's Prescription Plan, according to information from the FDA.

"The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. "This draft guidance is an important part of a larger effort by [the] FDA aimed at preventing prescription drug abuse and misuse."

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA Web site explains agency operations to public

Jan 12, 2010

(AP) -- The Food and Drug Administration is launching a new Web site explaining its operations to consumers as part of a broader effort to rebrand itself as a more accessible agency.

Recommended for you

Medical charity warns India over patent rules

Jan 21, 2015

Doctors without Borders on Wednesday warned the Indian government not to bow to US pressure to amend patent regulations that allow millions access to affordable medicines, ahead of a visit by President Barack Obama.

Why are some generic drugs getting so expensive?

Jan 21, 2015

More than eight out of every 10 prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in t ...

Supreme Court sides with Teva in drug dispute

Jan 20, 2015

The Supreme Court on Tuesday sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.