The FDA Releases Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid

24/03/2016

The FDA Releases Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

This guidance has been issued by the FDA mainly to assist a potential applicant who plans to develop, and submit an abbreviated new drug application (ANDA) to seek approval for, a generic version of a solid oral opioid drug product that has the potential for abuse and that references an opioid drug product with abuse-deterrent properties described in its labeling.

The guidance highlights general principles for developing and evaluating generic solid oral opioid ANDA products, incorporating chemical or physical deterrents to abuse. 

The document states that where an RLD possesses abuse deterrent features, studies must be performed for the ANDA to ensure that it too possesses the same levels of deterrent properties for all potential routes of abuse.  The guidance offers a detailed overview of what should be tested for and makes recommendations for what testing should be performed.

Guidance is given on a number of common methods for drug tampering and the evaluations that should be performed for each route to prove the efficacy of deterrence of the product.  The guidance also covers recommended comparative in vitro studies for chemical manipulation of the drug to further evaluate the deterrent properties of the product.  The FDA provides details on other considerations which could come into play for some applicants.  The guidance also offers an overview of the tier testing procedures.

For full details visit the website.

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