Pfizer’s Embeda Joins Abuse-Deterrent Club, But FDA Wants Assurances
This article was originally published in The Pink Sheet Daily
As with Purdue’s Targiniq, agency requires a post-marketing study to determine whether the new morphine/naltrexone formulation actually deters abuse.
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FDA reviewed all the categories of pre-marketing and post-marketing data outlined by guidance for abuse-deterrent opioids, but only in vitro and liking studies made it into the updated label.
There will be no generics of original OxyContin; FDA says it can no longer serve as a reference product because it has a greater abuse potential than the reformulation, where Purdue has secured particularly strong language regarding reducing intranasal abuse.
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.