1. Pink Sheet

Long-Term Opioid Efficacy Studies Will Take Years, Gottlieb Says

 
• By Derrick Gingery

Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.

Opioid abuse epidemic concept

Opioid manufacturers soon will be required to assess opioid efficacy changes during long-term use, but any labeling changes that may result likely are years away.

US FDA Commissioner Scott Gottlieb said the agency in "the next several months" will mandate that opioid manufacturers conduct randomized withdrawal studies to determine whether chronic use of opioids results in diminished efficacy

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