FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Advisory Committee Votes Against Liberal Definition of Opioid-Sparing Drugs

Nov. 30, 2018
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An FDA advisory committee voted against broad definitions of “opioid-sparing” and opioid-level analgesia in its November meeting.

The Anesthetic and Analgesic Drug Products Advisory Committee voted 11-1, with one abstention, against a definition of “opioid-sparing” as any drug that comprised any reduction in opioid use.

Members generally expressed doubts that the term was appropriate as a broad claim without context for the drug’s benefit-risk profile or consideration for the population, setting and variability in practice. “I don’t think any line of evidence would support a broad labeling of a drug as opioid-sparing,” said temporary member James Floyd, an assistant professor of medicine and epidemiology at the University of Washington.

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