The US Food and Drug Administration today released final guidance to assist the pharmaceutical industry in developing abuse-deterrent opioid drug products, in the hope that “safer” versions of these medications will hit the market soon.
The document, “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling,” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that an opioid formulation has abuse-deterrent properties, how the FDA will evaluate those studies, and what labeling claims may be approved on the basis of the results of those studies.
In working with industry, the FDA says it will take a “flexible, adaptive approach” to the evaluation and labeling of potentially abuse-deterrent products.
“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” FDA Commissioner Margaret A. Hamburg, MD, said in a news release. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”
Misuse or abuse of prescription opioids has skyrocketed in the United States and has become a major public health concern.
“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse deterrent properties,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the release. “While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”
During a media briefing today, Douglas Throckmorton, MD, CDER deputy director of regulatory programs, noted that the FDA received and reviewed “numerous comments” on draft guidance on abuse-deterrent opioid drugs put forth in 2013. “Overall, we think the final guidance will provide important information for developers that we anticipate will lead to the development of many new and successful abuse-deterrent opioid drugs,” he said.
The final guidance released today does not address generic opioid products. The agency is working on guidance in this area now and hopes to have a draft published “soon,” Dr Throckmorton said.
The overall goal is “a future in which most or all opioid medications are available in formulations that are less susceptible to abuse. It is a challenge [but] to date we’ve been cautiously optimistic,” Dr Throckmorton said. He noted that over 30 interested manufacturers have talked with FDA so far about developing these products, which would be reviewed under expedited processes to help speed them to market.
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