Abuse-Deterrent Opioids: FDA Finalizes Guidance for Generics

Regulatory NewsRegulatory News | 29 November 2017 |  By 

The US Food and Drug Administration (FDA) last week finalized guidance detailing its expectations for drugmakers looking to develop generic versions of abuse-deterrent opioids.

The guidance, which finalizes a draft issued in March 2016, maintains that generic versions of abuse-deterrent opioids must be "no less abuse deterrent" than the drug they are referencing for all potential routes of abuse.

According to guidance, this will help "minimize the risk of shifting abuse to other, potentially more dangerous, routes."

Notably, FDA has eliminated its recommendation that drugmakers use a control to identify discriminatory study conditions for comparing the proposed generic to the reference listed drug (RLD) and instead says that sponsors should conduct extraction studies to compare the abuse-deterrent properties of the two drugs.

FDA also says the guidance provides more detailed recommendations for conducting in vivo studies, such as comparative pharmacokinetic studies of manipulated products.

FDA Commissioner Scott Gottlieb said he hopes the guidance will encourage the development of abuse deterrent generic opioids.

"Until we're able to find new non-opioid 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,"

While FDA has so far approved 10 opioids with abuse-deterrent properties, such as pills that are difficult to crush or inject, the majority of opioids dispensed in the US are generic immediate release formulations and to date the agency has not approved any generic opioids with abuse-deterrent properties.

Part of the reason for the slow uptake of abuse-deterrent opioids, Gottlieb said, is due to their higher cost compared to the many non-abuse-deterrent generics on the market. Gottlieb also said that unfamiliarity with abuse deterrent technology and uncertainty about when such formulations should be prescribed also contributes to their wider use.

In addition to the final guidance, Gottlieb said FDA will work closely with generic sponsors to help them "navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable."

FDA, Statement


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy