2 November 2017 - Filing supported by positive Phase 3 APOLLO and ATHENA studies.

Trevena today announced that it has recently submitted its new drug application for Olinvo (oliceridine injection) to the U.S. FDA. Olinvo is the first G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator, and the first pain program to receive breakthrough therapy designation from the FDA.

The submission includes data showing that intravenous Olinvo demonstrated analgesic efficacy in all three dosing regimens tested in the two Phase 3 APOLLO pivotal efficacy studies. These trials were designed to support an indication for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted.

The filing also includes safety and tolerability data for over 1,100 patients administered Olinvo across Phase 2 and Phase 3 studies, including the ATHENA open label safety study. Additional pharmacokinetic data, clinical pharmacology data, and results from five randomised controlled trials with head to head comparisons to morphine support potential differentiation of Olinvo.

Read Trevena press release