BRIEF—FDA issues new product-specific guidelines on ADF opioids

The US Food and Drug Administration today posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for abuse-deterrent formulations (ADF) opioid products.

These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. In addition to the product-specific guidances issuing today, the FDA issued a final guidance last fall to assist industry in their development of generic versions of approved ADF opioids and support advancements in this area.

These product-specific guidances for ADF opioids are part of the FDA’s continued work to encourage drug developers to bring safe, effective and high-quality generic products to market, including hard-to-copy complex generics and products that don’t yet have generic competition.

These product-specific guidances, when finalized, will describe the FDA’s current expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.

The agency will continue to routinely post and revise product-specific guidances, including those for ADF opioids, as our goal is to decrease the rate of new addiction and to make the misuse and abuse of these drugs more difficult.

Commenting on the action, FDA Commission Dr Scott Gottlieb said: “We recognize that the science of abuse deterrence is relatively new, and we need to continue to study, and confirm, the potential role of ADFs in reducing the rate of misuse and abuse via different routes when used in a population. Both the formulation technologies and the methods for evaluating those technologies are rapidly evolving. We believe that transitioning from the current market, dominated by conventional opioid analgesics, to one where most opioids have abuse-deterrent properties may have the potential to further reduce misuse and abuse. While there are several of these products approved, their uptake has been slow among doctors who are treating patients in pain. One of the reasons for their more limited use is because these new formulations are currently only available as brand-name products, which are inherently more expensive than the numerous non-abuse-deterrent opioids that are also available in generic formulations. Many payers do not cover these ADF formulations.”