FDA: Draft guidance issued on abuse-deterrent opioids

January 10, 2013
FDA: draft guidance issued on abuse-deterrent opioids
The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.

(HealthDay)—The U.S. Food and Drug Administration has issued a draft guidance document to assist the pharmaceutical industry in developing new formulations of opioid drugs with abuse-deterrent properties.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This draft guidance fulfills mandates under the Safety and Innovation Act and the Office of National Drug Control Policy's Prescription Plan, according to information from the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 "This draft guidance is an important part of a larger effort by [the] FDA aimed at preventing prescription drug abuse and misuse."

Explore further: Teach prescribers about dangers of long-acting pain meds: FDA

More information: More Information

Related Stories

US panel opposes pure hydrocodone painkiller

December 9, 2012

(AP)—U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

Recommended for you

Researchers identify source of opioids' side effects

January 17, 2017

A commercially available drug may help drastically reduce two side effects of opioid painkillers—a growing tolerance and a paradoxical increased sensitivity to pain—without affecting the drugs' ability to reduce pain, ...

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

0 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.