FDA Issues Draft Guidance for Abuse-Deterrent Opioid Generics

Megan Brooks

March 24, 2016

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to help drug companies develop generic versions of approved opioids with abuse-deterrent formulations while ensuring that these products are no less abuse-deterrent than the brand-name drugs.

"Today's action reflects the important role that generic drugs play in the United States, especially for patients in pain," FDA Commissioner Robert Califf, MD, said during a media briefing. "With 100 million Americans with significant pain each year and 9 to 12 million with significant chronic pain, there is a large population at risk. Generics are crucial to delivering appropriate and affordable patient care.

"We recognize that abuse-deterrent technology is still evolving and is only one 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 medications is an important element in that strategy," Dr Califf added in a statement.

"A Work of Art"

The draft guidance, titled General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, includes recommendations to industry about the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.

The draft guidance is part of the FDA's recently announced action plan to reassess its approach to opioid medications. The plan includes new policies aimed at reversing the opioid abuse epidemic, while still providing patients who have severe pain access to effective relief, the agency said.

Today's draft guidance on developing generic versions of abuse-deterrent opioids follows similar guidance for brand-name opioids finalized by the FDA last year.

"The FDA looks forward to the day, hopefully soon, when the majority of opioids in the United States are marketed in effective abuse-deterrent forms. Today's action is an important step in that direction," Dr Califf said.

"I think this draft guidance is a work of art," he added. "As someone who has spent a career trying to translate scientific concepts into actions, this is like a textbook on how to think about abuse deterrence and how to translate the concepts into formulations that really have a promise of working."

To better understand the real-world impact of abuse-deterrent opioid formulations, the FDA will require sponsors of brand-name products with approved abuse-deterrent labeling to conduct long- term, epidemiologic studies to assess their effectiveness in reducing abuse in the real world.

This action "addresses twin challenges of ensuring needed access to appropriate treatment for pain and the need to address the tragedy of opioid abuse," said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research.

The FDA is seeking feedback from all stakeholders during the 60-day comment period on the draft guidance.

The FDA will hold a public meeting later this year to discuss the draft guidance on generic abuse-deterrent opioid products, as well as a range of other issues related to the use of abuse- deterrent technology as one tool to reduce prescription opioid abuse.

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