US FDA Faced With Suite Of Opinions Defining 'Clinically Meaningful' Opioid-Sparing Claims

Advisory committee agreed that statistically significant reduction in average opioid use and decrease in absolute amount were insufficient components on their own; a decrease in duration of use and a decrease in the amount of patients who don't need opioids received some support.

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The US FDA has some additional food for thought about how it should define a clinically meaningful decrease in opioid use to support an opioid-sparing claim, as members of the Anesthetic and Analgesic Drug Products Advisory Committee offered an array of opinions on a menu of options proposed by the agency.

At a Nov. 15 meeting on the assessment of opioid-sparing outcomes, members of the committee broadly agreed that a statistically...

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