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FDA project will examine abuse-resistant formulations

Published on 13/08/13 at 04:37pm
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The FDA is seeking tenders for a research project to examine how effective tamper-resistant formulations of opioid analgesics really are in preventing abuse and overdose.  

The new project comes in the wake of the agency's publication of draft guidance on abuse-deterrent opioid formulations in January, which set out FDA's current thinking on ways to prevent routes of abuse, such as crushing to snort or dissolving to inject the drugs.

"Drug overdose rates have been rising steadily in the US since 1970 with more than 15,500 deaths reported in 2009," says the FDA in documentation explaining the rationale for the new project.

Another key objective of the research project is to determine the criteria supporting the registration of generic versions of current abuse-deterrent opioid products, which currently include a reformulated version of Purdue Pharma's big-selling OxyContin (oxycodone hydrochloride) product that got the go-ahead in 2010 and Endo Pharmaceuticals' Opana ER (oxymorphone hydrochloride).

At the moment, the FDA will not accept or approve any generic forms of the earlier extended-release version of OxyContin, for example, particularly as it recently approved - for the first time - a specific claim for abuse-deterrence in the label of the newer version of the drug.

"If the FDA concludes that the newly approved opioid formulations significantly deter abuse, the agency will have the legal authority to require generic versions of those products to also have abuse-deterrent properties," according to the agency.

Specifically, the project will look at the physicochemical properties of the active pharmaceutical ingredients (APIs) and excipients in the composition of the drug product, along with the drug product manufacturing technology, to gauge their impact on the potential for extracting the active for abuse.

The researchers behind the project will also try to develop objective standards for abuse-deterrent properties using in vitro characterisation techniques to help the agency in its assessment of new marketing applications for opioid analgesics.

"Information generated from this research will assist in the assessment of innovator product claiming to have tamper resistant properties," says the FDA, adding: "it will also enable the development of needed equivalence standards to evaluate generic versions claiming abuse-deterrent properties".

The earlier draft guidance set out four categories of abuse-deterrence studies as well as the kinds of labelling language the FDA would consider approving.

The US Centers for Disease Control and Prevention (CDC) published a report last month which found that opioid abuse among women quadrupled between 1999 and 2010, while in men it rose two-and-a-half fold.

Phil Taylor



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