FDA: Draft guidance issued on abuse-deterrent opioids

FDA: draft guidance issued on abuse-deterrent opioids
The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.

(HealthDay)—The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.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This draft guidance fulfills mandates under the Safety and Innovation Act and the Office of National Drug Control Policy's Prescription Plan, according to information from the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 "This draft guidance is an important part of a larger effort by [the] FDA aimed at preventing prescription drug abuse and misuse."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

Supermaterial gives rejected drugs a new chance

12 hours ago

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

Risk of antibiotic overuse in aged care settings

Jul 21, 2014

Antibiotics are being overused in residential aged care facilities (RACFs), and more integrated efforts to improve antibiotic prescribing practices need to be introduced, researchers say. 

Ruconest approved for rare genetic disease

Jul 17, 2014

(HealthDay)—Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal ...

NIH system to monitor emerging drug trends

Jul 17, 2014

An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased ...

User comments