The FDA has outlined the type of studies opioids need to complete to win approval for abuse-deterrence.
The FDA has issued final guidance on the type of studies opioids need to complete to win approval for abuse-deterrence.
While opioids can provide significant benefits to patients experiencing pain, the drugs carry the risks of misuse, abuse, and death. Now, the FDA is encouraging drug manufacturers to develop effective opioids that also deter abuse.
“While drugs with abuse-deterrent properties are not ‘abuse-proof,’ the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse,” the administration stated.
According to the FDA, there are several ways in which opioids can be formulated to prevent abuse. For instance, physical barriers can prevent chewing, crushing, cutting, or opioids. Additionally, agonist combinations can interfere with, reduce, or defeat the euphoria from abusing an opioid. Nevertheless, the FDA encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies.
“FDA is concerned that, with time, abusers may adapt to abuse-deterrent technologies and discover methods to defeat them,” the guidance document states. “If and when abusers can overcome a technology such that it no longer has a meaningful effect in deterring abuse, FDA may require labeling revisions.”
Presently, reformulated Oxycontin, Targiniq, Hysingla, and Embeda can make the coveted abuse-deterrent label claims. Although Opana and Zohydro have abuse-deterrent formulations, the FDA has not approved the abuse-deterrent claim for either product.
To inform health care professionals and patients of a product’s abuse potential, the FDA encourages drug developers and manufacturers to promote labeling that appropriately characterizes the abuse-deterrent properties of their opioids, such as specifications on how to prevent crushing or grinding.