At meeting on Pacira's Exparel, advisory committee members warn against rushing to adopt products purported to reduce opioid consumption absent long-term longitudinal data showing beneficial public health impacts and clinical data linking reduced opioid use to functional outcomes or other clinical benefit.
If Pacira Pharmaceuticals Inc.'s US FDA advisory committee experience with Exparel (bupivacaine liposome injectable suspension) is any indication, sponsors seeking to label their products as having opioid-sparing effects may face a high evidentiary bar for making such claims.
Merely showing that a non-opioid product resulted in reduced use of an opioid in a placebo-controlled trial is not enough...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
