Positive US FDA advisory panel view on PAMORAs
The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members yesterday voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.
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