US-based biopharmaceutical company Trevena has reported positive top-line results from two Phase III clinical trials (APOLLO-1 and APOLLO-2) of oliceridine to treat moderate-to-severe acute pain after bunionectomy and abdominoplasty.
Oliceridine injection is an intravenous (IV) analgesic designed to improve conventional opioid pharmacology to provide the pain-reducing potential of an opioid with minimum associated adverse effects.
The results indicated that all dose regimens met their primary endpoint of statistically greater analgesic efficacy measured by responder rate and showed dose-related trends of improvements on measures of respiratory safety and gastrointestinal tolerability when compared to morphine.
Both the multicentre, randomised, double-blind, placebo-controlled and active-controlled Phase III trials evaluated the efficacy of the injection, but APOLLO-1 involved bunionectomy while APOLLO-2 involved abdominoplasty.
Trevena chief executive officer Maxine Gowen said: “We believe the data for all three dose regimens will support the US Food and Drug Administration (FDA) approval of IV oliceridine with a broad indication of management of moderate-to-severe acute pain.
"These successful trials cap a development programme that has shown consistent differentiation of oliceridine from morphine in multiple clinical trials."
The trial's secondary endpoints included comparisons of the injection's efficacy, safety and tolerability to morphine.
A multi-procedure safety Phase III ATHENA trial is also being carried out to evaluate oliceridine in more than 400 patients.
Trevena has received breakthrough therapy designation for oliceridine from the FDA and plans to submit the new drug application (NDA) in the fourth quarter of this year.