The Food and Drug Administration (FDA) released a draft guidance regarding the development of generic versions of opioids with abuse-deterrent formulations (ADF) to ensure that they are no less abuse-deterrent than the brand-name version.
The draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products”, follows the FDA’s final guidance for brand name opioids titled “Abuse-Deterrent Opioids – Evaluation and Labeling” from April 2015. The FDA is continuing to encourage the development of pain drugs that are more difficult to abuse where the properties of the drug make certain types of abuse (eg, crushing, snorting, injecting) more difficult or less rewarding. To date, the Agency has not approved an opioid with properties that are expected to deter abuse if swallowed whole.
All sponsors of brand-name drugs with approved abuse-deterrent labeling are now required to conduct long-term epidemiological studies to assess the efficacy in lowering abuse in practice. The FDA noted that encouraging access to generic 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.”
The guidance includes recommendations on the studies that should be conducted to show that a generic opioid is no less abuse-deterrent than the brand-name version in regards to all possible routes of abuse.
Feedback from all stakeholders is encouraged during the 60-day comment period on this draft guidance.
For more information visit FDA.gov.