Trevena announced positive topline results from two Phase 3 studies of oliceridine for the treatment of moderate-to-severe acute pain following bunionectomy (APOLLO-1) and abdominoplasty (APOLLO-2).
APOLLO-1 and APOLLO-2 were both multicenter, randomized, double-blind, placebo- and active-controlled Phase 3 trials evaluating the efficacy of oliceridine for 48 hours following bunionectomy and 24 hours following abdominoplasty, respectively. Patients received a loading dose of placebo, morphine 4mg or oliceridine 1.5mg, followed by on-demand doses of the same study drug (morphine 1mg or oliceridine 0.1mg, 0.35mg, or 0.5mg) via patient controlled analgesia (PCA).
The primary endpoint was analgesic efficacy of oliceridine compared to placebo, as measured by responder rate. Secondary endpoints included comparisons of efficacy, safety, and tolerability of oliceridine to morphine, including incidence of nausea and vomiting and respiratory safety measures.
Results from APOLLO-1 showed that all three doses of oliceridine (0.1mg, 0.35mg, 0.5mg) demonstrated statistically greater analgesic efficacy than placebo at 48 hours post-bunionectomy (p<0.0001, adjusted for multiplicity). Both the 0.35mg and 0.5mg oliceridine doses showed non-inferior efficacy to morphine based on responder rate (P<0.005), as well as comparable rescue analgesic usage. In addition, all three doses exhibited a dose-related trend of improved respiratory safety burden and a dose-related trend of lower prevalence of nausea and vomiting (P<0.05 for the 0.1mg dose vs. morphine in both measures).
Findings from the APOLLO-2 study showed that all three oliceridine doses demonstrated statistically superior responder rates vs. placebo at 24 hours post-abdominoplasty (adjusted P<0.05 for 0.1mg; adjusted P<0.001 for 0.35mg and 0.5mg). Both 0.35mg and 0.5mg doses showed non-inferior efficacy to morphine (P<0.005 for 0.35mg), with comparable rates of rescue analgesic use. Similarly, oliceridine showed a dose-related trend of improved respiratory safety burden in all three doses (P<0.05 for 0.1mg dose vs. morphine), as well as a dose-related trend of lower prevalence of nausea and vomiting (P<0.05 for the 0.1mg regimen vs. morphine for both nausea and vomiting; P<0.05 for 0.35mg vs. morphine for vomiting).
Both studies found oliceridine to be generally safe and well-tolerated, with the most common adverse events presenting as nausea, vomiting, headache, and dizziness. Full results of APOLLO-1 and APOLLO-2 will be presented at a future scientific conference or in a peer-reviewed publication.
Oliceridine is a next generation injectable analgesic specifically designed to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects. Trevena also announced that the FDA has conditionally accepted Olinvo as its proprietary brand name and expects for a Schedule II controlled substance designation.
For more information visit Trevena.com.