FDA panel discusses CV outcomes trials in OIC
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. ...