Tamper-Resistance Could Allow New Opioid Formulations To Differentiate Themselves
A claim for tamper-resistance rather than broad abuse-deterrence appears to be the immediate path forward for companies seeking to differentiate a new opioid product by its ability to impede recreational use.
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Opioid Abuse-Deterrent Labeling Claim Decision By FDA Could Come Soon
Purdue epidemiological studies indicate reformulation of OxyContin had a positive effect on abuse and misuse of the drug, but the company says continued monitoring is needed to assess whether the positive trend continues.
Abuse Reduction Claim In Opioid Label Will Be Difficult To Attain
FDA draft guidance says there is no clear epidemiologic strategy for gathering the data to demonstrate that has reduced abuse; the agency outlines four possible kinds of abuse deterrence claims, three of which can be obtained through pre-market studies.
Opioid Abuse-Deterrent Formulations Could Become Prerequisite To Approval
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.