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FDA panel discusses CV outcomes trials in OIC

June 12, 2014 11:32 PM UTC

The majority of panelists on FDA's Anesthetic and Analgesic Drug Products Advisory Committee felt cardiovascular outcomes trials weren't warranted for peripheral mu opioid receptor ( OPRM1; MOR) antagonists to treat opioid-induced constipation (OIC) in patients with chronic non-cancer pain. The consensus was the safety signal was weak and only occurred in one Phase III study of Entereg alvimopan from Cubist Pharmaceuticals Inc. (NASDAQ:CBST).

Initially, 12 of 24 panelists voted against requiring CV outcomes trials. FDA then clarified the CV outcomes trial would be a randomized controlled study and not a post-market observational study. Afterwards, five members who had voted to require the study changed their vote to no, making the unofficial tally 17-7 against requiring CV outcomes studies. ...