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Abuse-Deterrent Opioids: Postmarketing Data Eyed As Development ‘Anchor’

 
• By Michael Cipriano

Panelists at US FDA advisory committee on Inspirion's RoxyBond note reservations about abuse-deterrent claims absent more real-world data on how they work; FDA's Staffa suggests agency is eager to see how well premarket work predicts postmarket experience – though the data are far from being available.

Recent US FDA advisory committees have struggled with the lack of real-world data on how well abuse-deterrent opioids actually curtail abuse, but the most recent discussion underscores how the agency will look to postmarket studies to shape development requirements.

“I think we don’t know at all yet what these products are actually doing in the marketplace, but we are all trying to figure that out," Judy Staffa, associate director for public health initiatives in the Office of Surveillance and Epidemiology, said at an April 5 advisory committee meeting assessing

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More from US FDA Performance Tracker

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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