Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee
US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
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Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.