Opioid-Sparing Regimens Face High Hurdles After US FDA Advisory Cmte.
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.
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In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.
FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
Once the National Academies of Sciences, Engineering and Medicine find conditions needing more evidence to support prescribing guidelines, the agency may have find a way to gather the data.