Access to the PPM Journal and newsletters is FREE for clinicians.

FDA Encourages More Development of Generic Versions of Abuse Deterrent Formulations

Current ADF products have had a slow uptake among practitioners

A PPM Brief

FDA recently announced1 that it is encouraging the development of  generic versions of opioids with abuse-deterrent formulations (ADFs), intended to curb abuse (crushing, dissolving), making it harder to manipulate these drugs for an immediate “high.”

The agency noted 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,” according to the statement. With the technology evolving, FDA believes that transitioning most market opioids to have abuse-deterrent properties will drastically reduce opioid misuse and abuse. The statement noted that ADFs are mostly expensive, brand name products that are not covered by many payers, which means that they have been slow to implement among doctors.

In the statement, FDA has released three revised product-specific guidances for ADF opioid products to its list of 43 new or revised product-specific guidances for the development of generic drug products; recommending specific in vivo and in vitro study considerations for abuse deterrence evaluations. While issued as a current expectation to developing generic drug products, the agency noted that the ADF guidances will “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.”

The agency concluded by saying that it will continue to routinely post and revise product-specific guidances (including those for ADF opioids) in an effort to decrease the rate of addiction, and make misuse and abuse more difficult.

Last updated on: July 24, 2018
Continue Reading:
Abuse-Deterrent Formulations
close X