Unintended Consequences Of Broad Opioid-Sparing Claims Worries US Panel
FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
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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.
The agency is assessing whether to use different language to describe addiction and abuse deterrence.
Panelists felt the phrase "opioid sparing" was too broad, and contended that it is difficult to develop a non-opioid alternative without an opioid as an active comparator.