BioCentury
ARTICLE | Clinical News

Entereg alvimopan regulatory update

June 16, 2014 7:00 AM 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 a safety signal was weak and only occurred in 1 Phase III trial of Cubist's Entereg alvimopan.

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 postmarkeing observational study. Afterwards, 5 members who had voted to require the study changed their vote to no, making the tally 17-7 against requiring CV outcomes studies. ...