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FDA AdCom recommends no CV trial for AstraZeneca PLC's PAMORA class


Friday, 13 Jun 2014 02:00am EDT 

AstraZeneca PLC:Says majority of Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that FDA should not require cardiovascular outcomes trials for peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs.Says 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.Says If approved, MOVANTIK has potential to be first once-daily, oral PAMORA for the treatment of OIC for patients with chronic non-cancer pain.MOVANTIK is also under regulatory review with health agencies in the European Union and Canada. 

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17 Dec 2014