1. Pink Sheet

Opioid Long-Term Effectiveness: FDA Postmarket Trial Design Offers ‘Best Compromise’

 
• By Brenda Sandburg

FDA advisory committee to consider proposed protocol to meet postmaketing requirement set a decade ago to determine risk of hyperalgesia following long-term use of ER/LA opioid analgesics. Initial trial was terminated in 2018 due to inability to recruit enough patients.

Opioid prescription
FDA panel to discuss postmarket clincial trial on long-term effectiveness of opioid analgesics • Source: Shutterstock

A decade after the US Food and Drug Administration required makers of extended-release and long-acting opioid analgesics to conduct a post-marketing study on the risk of opioid-induced hyperalgesia, manufacturers and the agency have a proposed protocol for review by its outside experts.

The agency’s Anesthetic and Analgesic Drug Products Advisory Committee will discuss the protocol at its 19 April meeting. In its

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