FDA to hold public meeting on abuse-deterrent opioid formulations

Scott Gottlieb, FDA commiossioner

The US Food and Drug Administration (FDA) is holding a public meeting in July to discuss the role of opioid formulations that are intended to prevent abuse and addiction.

The agency’s commissioner Scott Gottlieb said in a press statement that while such products “may hold promise” in deterring abuse, there is currently a lack of real-world evidence as to their impact.

The public workshop will focus on how to improve analysis of existing data and how to optimise future studies. It will also include discussion of ways to improve national surveillance and research capabilities in the area.

“The FDA is committed to looking at all facets of this complex issue and collaborating on various approaches, as there are no simple answers to reverse this epidemic,” said Gottlieb.

Abuse-deterrent technologies are relatively recent and include a number of strategies. These include adding physical barriers to prevent the grinding and crushing of tablets, or the inclusion of gelling agents that resist solvent extraction. Another example is the incorporation of an opioid antagonist such as nalaxone that becomes activated when manipulated and counteracts the euphoria associated with the drug.

The FDA’s position is that it encourages the development of such formulations and it has approved labelling for a number of non-generic opioid medications, allowing them to describe abuse-deterrent properties.

Last month, the FDA announced new policy steps, which it said were part of a more forceful approach to tackling the country’s opioid addiction epidemic. The steps included the formation of a steering committee focused on preventing new cases of addiction.

Earlier this week, the FDA also announced it had requested the withdrawal of an abuse-deterring opioid formulation called Opana ER. They said that a reformulation of the drug with a coating to prevent abuse from snorting had driven abusers to inject the drug instead, resulting in an outbreak of HIV and hepatitis C virus.

The workshop will be held in Maryland on 10 and 11 July 2017.

Last updated
The Pharmaceutical Journal, June 2017;():DOI:10.1211/PJ.2017.20203009

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