P70 - APOLLO-1: a Randomized, Controlled, Phase 3 Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Pain Following Bunionectomy

Abstract

BACKGROUND CONTEXT: Conventional opioids are the foundation of moderate to severe postoperative pain management. However, conventional opioids are associated with a variety of opioid-related adverse events (ORAEs), including respiratory depression and gastrointestinal intolerability, which limit their utility for acute pain. Some conventional opioids also are limited by a slow onset of action that can lead to excessive dosing and, thus, an increased risk of ORAEs. Conventional opioids bind to µ receptors and activate two intracellular signaling pathways: the G protein pathway (associated with analgesia) and the β-arrestin pathway (associated with ORAEs and inhibition of G protein-mediated analgesia). Oliceridine (TRV130) is a novel analgesic that acts as a µ receptor G protein Pathway Selective (µ-GPS) modulator to activate G protein signaling with decreased β-arrestin recruitment. Oliceridine, therefore, offers the potential for effective analgesia with improved tolerability and fewer ORAEs. In Phase 2 studies, oliceridine produced rapid analgesia with an improved safety/tolerability profile compared with morphine.