FDA issued draft guidance for developers of generic versions of approved opioids with abuse-deterrent properties describes in their labels.
The draft guidance, titled General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Product, includes recommendations to industry about the studies needed to show that a generic opioid is no less abuse-deterrent than the brand-name drug, with respect to all potential routes of abuse. This includes comparative in vitro studies using a tier-based approach to compare mechanical and chemical manipulation of the generic vs. the reference opioid.
“Today’s action reflect the important role that generic drug play in the United States, especially for patients in pain,” said FDA Commissioner Rebert Califf. “With 100 million Americans with significant pain each year and 9 to 12 million with significant chronic pain, there is no large population at risk. Generic are crucial to delivering appropriate and affordable patient care.”
Dr Califf added in a statement, “We recognize that abuse-deterrent technology is still evolving and is only once piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medication is an important element in that strategy.”
Comment of draft guidance are due May 24. FDA plans to hold a public meeting this year to discuss the guidance.