FDA Officials Release Guidances for Generic of Abuse-Deterrent Opioids

Opioid analgesics made with abuse-deterrent formulations (ADFs) are a prominent strategy designed to combat the opioid epidemic.

Despite their effectiveness in making abuse via alternative routes more difficult and less pleasurable, they have yet to be implemented in common prescribing practice.

FDA officials have said although ADFs are a big step in the right direction, further measures are necessary to increase accessibility and encourage a widespread market shift from traditional opioids to ADFs. To address this concern, the FDA released 43 new or revised product-specific guidances to push generic drug development, including 3 that directly address generic ADF opioid products.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement.¹ “Many payers do not cover these ADF formulations.”

The FDA addresses this issue by recommending studies to evaluate the efficacy of ADFs both in vivo and in vitro in the new guidances.

“These product-specific guidances for ADF opioids are part of our 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,” Gottlieb said.

The new guidances are a follow-up to the finalized guidance issued last fall to push the industry to develop generic versions of the approved ADF opioids.

“Until we’re able to find new nonopioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence,” Gottlieb said in a 2017 statement about the new guidance.²

Once the recent guidances are finalized, they will highlight the FDA expectations for the development process of generic drug products that are equivalent to the specific drugs listed, including ADF opioids.

Moving forward, the FDA plans to continue working to advance the development of generic ADF opioids.

“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,” Gottlieb said.

REFERENCES

1. FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids [news release]. Silver Spring, MD: FDA; July 20, 2018. www.fda.gov/NewsEvents/ Newsroom/FDAInBrief/ucm614098.htm. Accessed July 27, 2018.

2. Statement from FDA Commissioner Scott Gottlieb, MD, on steps to promote development of generic versions of opioids formulated to deter abuse. Silver Spring, MD: FDA; November 21, 2017. www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm586117.htm. Accessed July 27, 2018.