Trevena's Intravenous Opioid Will Face Difficult US FDA Advisory Committee
Executive Summary
Oliceridine is not superior to morphine, has abuse potential similar to other mu opioid agonists, FDA concludes; also endpoint Trevena used to evaluate respiratory safety was inadequate, FDA says.
You may also be interested in...
Keeping Track: FDA Starts November With A Bang
The latest drug development news and highlights from our FDA Performance Tracker.
Trevena's IV Opioid Not Quite 'Ready for Primetime,' US FDA Panel Concludes
Advisory committee votes 8-7 against approval of the novel opioid; several members say they would change their vote with more data.
After APOLLO: Trevena Weighs Commercial Viability Of Opioid Oliceridine
A mixed bag of safety results for the new opioid Olinvo (oliceridine) in the Phase III APOLLO pain trials disappoints the market, but analysts are encouraged by the totality of the data and optimistic about approval.