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.
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Advisory committee votes to add oxycodone to do-not-compound list, but will compounders now begin producing abuse-deterrent formulations?
As with Purdue’s Targiniq, agency requires a post-marketing study to determine whether the new morphine/naltrexone formulation actually deters abuse.
The agency finds reformulated Opana insufficient to deter abuse through most routes of administration and decides the original version was not removed from the market for efficacy and safety reasons; Endo had weaker in vitro and post-market data than Purdue did in its successful Oxycontin petition.