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.
You may also be interested in...
Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected
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.
Unintended Consequences Of Broad Opioid-Sparing Claims Worries US Panel
FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
US FDA Likely Cannot Force Sponsors To Fund Opioid Prescribing Guideline Trials
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.