AstraZeneca PLC (AZN) Release: FDA Adcom Recommends No CV Trial For PAMORA Class
6/13/2014 8:15:47 AM
AstraZeneca announced today that the majority of US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes MOVANTIKTM (naloxegol oxalate), an investigational treatment for opioid -induced constipation (OIC) for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.
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