Abuse-Deterrent Opioid Manufacturers Want FDA To Set Conversion Deadline
US agency denied group's 2013 citizen petition, but with more abuse-deterrent products on the market, sponsors hope climate is more favorable for idea that older opioids should come off market once three similar abuse-deterrent products are available.
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Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.
Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.
US FDA says it expects to finalize guidance by November, but more research is needed with generic development questions lingering.