Intravenous (IV) oliceridine can effectively and safely help manage moderate-to-severe post-surgical pain, according to results of a phase 3 study presented at the 2017 Annual Meeting of the American Society of Anesthesiologists (ASA).
Eugene R. Viscusi, MD, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and colleagues assessed the proportion of patients who responded to oliceridine compared with placebo. They also assessed the efficacy and safety of the drug compared with morphine.
The researchers randomised subjects with moderate or severe pain following bunionectomy into 1 of 5 double-blind, 48-hour treatment regimens, comprising IV oliceridine (1.5-mg loading dose; 0.1-mg, 0.35-mg or 0.5-mg demand doses), volume-matched placebo, or morphine (4-mg loading dose; 1-mg demand doses) administered as needed by a patient-controlled analgesia (PCA) device with a 6-minute lockout. The team provided etodolac as necessary for rescue analgesia.
This study defined treatment responders as patients who experienced at least a 30% improvement in pain-intensity difference 48 hours after baseline without receiving rescue analgesia, without discontinuing oliceridine early, and without reaching dosing limits.
Dr. Viscusi and colleagues found that all oliceridine treatment regimens were superior to placebo in terms of treatment responders. The 0.35-mg and 0.5-mg oliceridine dose regimens demonstrated efficacy comparable with morphine at 48 hours, and were also comparable with morphine for rates of rescue analgesic use.
The researchers further determined that, following the 1.5-mg initial dose of oliceridine, the drug demonstrated a rapid onset of efficacy compared with morphine.
All oliceridine regimens demonstrated lower respiratory safety burdens compared with morphine, although only the 0.1-mg regimen reached the level of statistical significance.
The proportion of patients requiring rescue anti-emetics was significantly lower in all oliceridine groups compared with morphine; most exhibited lower frequencies of nausea and vomiting, although, again, only the 0.1-mg regimen reached the level of statistical significance.
Oliceridine is designed to deliver the pain-reducing potential of opioids, but with fewer associated side effects, such as nausea and vomiting, and opioid-induced respiratory depression.