FDA issues guidance for abuse-deterrent formulations

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance that will help the pharmaceutical industry in its development of approved generic opioid drugs that contain abuse-deterrent formulations (ADF).

The FDA will also make certain that these generic ADF opioids are no less abuse-deterrent than the brand-name counterparts.

The actions taken by the FDA are part of the agency’s action plan to reexamine its approach to opioid medicines. The plan is derived from policies aimed at putting a stop to the nationwide opioid epidemic while still allowing patients who are in legitimate need of the medications access to them.

The guidance issued by the FDA is encouraging the pharmaceutical industry to create pain medicines that are harder to abuse. The abuse-deterrent properties proposed by the FDA make specific types of abuse more difficult or less rewarding. These types of abuse include crushing tablets in order to snort them or dissolving capsules to inject its contents. However, the ADF properties of the newly developed medicines will not make abuse impossible and will not entirely prevent addiction, overdose or death.