- Posted by Austin Swim
- On April 7, 2015
- 0 Comments
Because of the alarming rates seen in opiate and opioid abuse today, the Federal Drug Administration has been working on guidelines to help prescription drug developers in developing opioid drugs that have abuse-deterrent properties. Most recently, the FDA issued a final piece of guidance to assist industry in the form of a document titled “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.”
The document covers the FDA’s current thinking on which studies should be pursued in determining how effective current abuse-deterrent opioids are, including information on how these studies should be carried out and reported. This information is vital to prescription drug developers because how these studies are carried out and the results of these studies will dictate which opioid label claims are approved.
As the field of abuse-deterrent opioid manufacture is still relatively new, the FDA is working with drug manufacturers to help the field’s advancement.
For more information on the new guidelines from the FDA, you can find a full article here.