Pfizer Will Study Oxecta Abuse/Misuse Potential Post-Market
This article was originally published in The Pink Sheet Daily
Executive SummaryFDA okays the opioid, which contains abuse-resistant components, with labeling about a study that found the drug less likeable than immediate-release oxycodone.
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Agency says it is seeing confusion in the marketplace when it comes to distinguishing between agency-approved labeling claims and advertising about products that are intended to be abuse deterrent.
The sponsor believes its data package could support a labeling claim that the drug “is expected to result in a meaningful reduction in abuse”; the agency’s review could indicate the strength of data needed to support such a claim.