Findings published from phase III trial of patients with moderate-to-severe acute postoperative pain
THURSDAY, July 11, 2019 (HealthDay News) — Oliceridine is being proposed as an analgesic option for the relief of moderate-to-severe acute postoperative pain, according to a study recently published in Pain Practice.
Neil K. Singla, M.D., from Lotus Clinical Research in Pasadena, California, and colleagues randomly assigned 401 patients with moderate-to-severe acute postoperative pain following abdominoplasty to a loading dose of placebo, oliceridine (1.5 mg), or morphine (4 mg), followed by demand doses administered through patient-controlled analgesia (0.1, 0.35, or 0.5 mg oliceridine; 1 mg morphine; or placebo) with a six-minute lockout interval.
The researchers found that effective analgesia was achieved with all oliceridine regimens, with responder rates of 61.0 percent for the 0.1-mg demand dose regimen, 76.3 percent for the 0.35-mg regimen, and 70.0 percent for the 0.5-mg regimen versus 45.7 percent for placebo and 78.3 percent for morphine. Equivalent analgesic effect was seen for oliceridine 0.35- and 0.5-mg regimens, compared with morphine. The respiratory safety burden (RSB) demonstrated a dose-dependent increase across oliceridine regimens (mean hours, 0.1 mg: 0.43; 0.35 mg: 1.48; 0.5 mg: 1.59, compared with placebo [0.60]; the RSB measure for morphine was 1.72). There was also a dose-dependent increase in gastrointestinal adverse events across oliceridine demand dose regimens (0.1 mg: 49.4 percent; 0.35 mg: 65.8 percent; 0.5 mg: 78.8 percent, compared with placebo [47.0 percent] and morphine [79.3 percent]). However, the proportion of patients experiencing nausea or vomiting was lower with 0.35- and 0.5-mg oliceridine versus morphine.
“These findings support that oliceridine may provide a new treatment option for patients with moderate-to-severe acute pain where an intravenous opioid is warranted,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Trevena, which manufactures oliceridine and sponsored the study.
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