FDA Issues Draft Guidance on Abuse-Deterrent Formulations for Generics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-29-2016 14:37


The US Food and Drug Administration (FDA) has issued a draft guidance intended to support industry in its development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. The draft guidance recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its reference listed drug.

In the draft guidance, the agency is encouraging industry efforts to develop pain medicines that are more difficult to abuse. Abuse-deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject its contents, more difficult or less rewarding. It does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death, according to the FDA.

To better understand the real-world impact of ADF therapies and continue to support innovation in this space, the FDA has required all sponsors of brand name products with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in practice. While the FDA recognizes that the ADFs are not failsafe and more data are needed, ADF opioids do have properties expected to deter abuse compared to non-ADFs.

"Given the lower cost, on average, of generic products, encouraging access to generic forms of ADF opioids is an important step toward balancing the need to reduce opioid abuse with helping to ensure access to appropriate treatment for patients in pain," said the FDA in a statement.

The draft guidance, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products,includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse. This draft guidance for generic abuse-deterrent opioids follows the agency’s final guidance for brand name opioids, Abuse-Deterrent Opioids-Evaluation and Labeling, which was issued April 2015 as the first step to provide a framework for what studies were needed to test a product’s ability to deter abuse.

To encourage additional input from outside experts and the public, the FDA will also hold a public meeting later this year to discuss the draft guidance on generic ADF products and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse. The FDA will take this feedback into consideration when developing the final guidance on this topic.

The FDA is accepting comments on the draft guidance until May 24, 2016.

Source: US Food and Drug Administration


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