March 31, 2016
Due to recent increases in the prevalence of opioid abuse and misuse, the opioid epidemic has attracted a lot of attention lately. As such, the FDA is taking an active approach to reduce the occurrence of this issue in the U.S.
As we reported yesterday, the Agency’s latest effort in the fight against opioid abuse is the release of its draft guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.”
When attempting to abuse opioids, there are a number of ways they can be ingested. These include:
When ingesting opioids orally, users can do so in a variety of ways. As such, opioids can be swallowed as intact dosage forms or “after chewing, cutting, crushing, grating, milling, or extracting the opioid from the intact or mechanically manipulated form.”
In order to help combat these alternate routes of administration, the FDA believes that all potential routes of abuse should be taken into consideration when evaluating the abuse deterrence of generic opioids.
FDA recommends that sponsors use a tier-based approach when comparing the abuse deterrence of the generic and reference products. This means that “in vitro testing should start with simple and gentle manipulations and progress to complex and more destructive manipulations.”
In addition to mechanical manipulation, the draft guidance states that sponsors can also use chemical manipulation, in which different levels of solvents may be used to extract the opioid. The guidance “recommends the following levels of solvents be used for chemical manipulation in comparative in vitro studies:
Applicants interested in using other solvents are encouraged to seek input from the Agency regarding additional testing suitable for product-specific development.
In addition to the recommendations provided above and in our previous FDA News article, the draft guidance includes a number of factors to consider, including:
FDA is seeking public feedback on the draft guidance and is asking interested parties to submit comments electronically or by mail no later than May 24, 2016.
For additional information on FDA’s recommendations, view the full draft guidance.
Want to learn more about the opioid epidemic? View our additional FDA News articles on the subject:
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