FDA Issues Draft Guidance for Development of Abuse-Deterrent Opioids
The FDA has announced the steps it plans to take in order to expand the use of abuse-deterrent opioids.
The US Food and Drug Administration (FDA) has announced the steps it plans to take in order to expand the use of abuse-deterrent opioids.
The draft guidance, titled "General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products," aims to encourage industry efforts to promote pain medications developed to curb abuse. It advocates for generic versions of abuse-deterrent formulations, but it also stresses the importance of ensuring that these painkillers should be no less abuse-deterrent than brand-name versions.
"For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care," FDA Commissioner Robert Califf, MD, said in a statement. "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."
The 34-page document covers abuse deterrence of generic solid oral opioid drug products; general principles for evaluating the abuse deterrence of generic solid oral opioid drug products; routes of abuse; in vitro testing; and other considerations.
Even with abuse-deterrent properties, which work to prevent pills from being crushed or dissolved, opioids can still be abused if they are swallowed whole. As of yet, the FDA has not approved an opioid product with properties that are expected to deter abuse if it is ingested entirely.
The agency will hold a public meeting later this year to discuss its report and other issues related to use of abuse-deterrent technology.
"Collaboration is critical in fostering innovation in the field of abuse deterrence," Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said in a statement. :It is essential that a generic product is no less abuse-deterrent than the brand name product."
FDA takes important step to increase the development of, and access to, abuse-deterrent opioids. US Food and Drug Administration (FDA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm492237.htm. Accessed March 28, 2016.