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Opioid Long-Term Effectiveness Trial Design Gets Middling Review From FDA Panel

 
• By Brenda Sandburg

Advisory committee agrees that a proposed study protocol could enroll patients but notes the outcome is foreseeable. Industry representative questions whether this postmarketing requirement is necessary.

Pain killer
Proposed study to assess long-term efficacy of opioids gets FDA panel review • Source: Shutterstock

A US Food and Drug Administration advisory panel had a lukewarm response to a proposed clinical trial design to assess the long-term efficacy of extended-release and long-acting opioids. Members said the design is feasible but the results are predictable.

The Anesthetic and Analgesic Drug Products Advisory Committee discussed the study protocol at its 19 April meeting. The agency requested that manufacturers conduct the clinical trial as a post-marketing requirement (PMR) in 2013

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