Trevena confirmed that it remains on track to file an NDA with the FDA later this year for its intravenous analgesic oliceridine (TRV130) on the back of positive topline data from two placebo-controlled Phase III studies. The pivotal APOLLO-1 and APOLLO-2 studies evaluated three doses of oliceridine in the management of moderate-to-severe acute pain following bunionectomy (APOLLO-1) and abdominoplasty, (APOLLO-2).

Data reported today confirmed that both trials met their primary responder rate endpoints and also demonstrated efficacy comparable with that of morphine, based on responder rates. Additional trial data indicated that oliceridine therapy may demonstrate improved respiratory safety and gastrointestinal tolerability when compared with morphine.

“We believe the data for all three dose regimens will support FDA approval of IV oliceridine with a broad indication of management of moderate-to-severe acute pain,” commented Maxine Gowen, Ph.D., Trevena CEO. “These successful trials cap a development program that has shown consistent differentiation of oliceridine from morphine in multiple clinical trials.”

“These data are exciting—they confirm earlier data and show an improved safety and tolerability profile of oliceridine compared to morphine, with very similar results across the two studies,” added Timothy Beard, M.D., FACS, chair of the Department of Surgery, Bend Memorial Clinic, Oregon. 

Another ongoing Phase III safety study, ATHENA, is evaluating oliceridine in multiple procedures. The drug has been granted breakthrough therapy designation by FDA.

Oliceridine binds to the mu receptor, but unlike traditional opioid drugs, is designed not to trigger the pathway that causes opioid-related adverse effects. Trevena's clinical pipeline includes TRV734, an oral follow-on program to intravenous oliceridine, which has completed Phase I studies for the treatment of acute and chronic pain.

Trevena is exploiting its ABLE™ platform to discover and develop biased ligands targeting G protein-coupled receptor (GPCRs). The firm has focused its development efforts on the oliceridine program since mid-2016, when a second clinical candidate, an AT1R biased ligand TRV027, failed to meet both primary and secondary endpoints in a Phase IIb study in acute heart failure.