Oliceridine, an investigational G-protein biased mu-opioid receptor ligand, was found to be safe and effective for acute pain management across diverse patient populations and surgeries, according to new phase 3 data.
The ATHENA-1 study was an open-label trial evaluating the safety of intravenous (IV) oliceridine in patients with moderate-to-severe acute pain caused by medical conditions or surgery for which parenteral opioid therapy is warranted (N=768). Patients (mean age: 54.1 years) were administered oliceridine by IV bolus, PCA, or both; the primary outcome measure was adverse events reported from the first dose through 3 days after the end of the treatment phase.
The study included patients with body mass index ≥30kg/m2 (46%), as well as those with comorbidities such as diabetes, cancer pain, and obstructive sleep apnea; 94% of the population was comprised of patients with post-surgical acute pain (most common: orthopedic, colorectal, and gynecological procedures).
Results showed adverse events were found to be mostly mild or moderate in severity; the most common treatment-emergent events included nausea, vomiting, and constipation. “Oliceridine provided a rapid reduction in [Numerical Rating Scale] pain score by 2.2 ± 2.3 at 30 minutes from a score of 6.3 ± 2.1 (at baseline) which was maintained to the end of treatment,” study authors reported.
Based on these findings, they concluded that treatment with oliceridine IV was generally safe and well-tolerated. “Additionally, oliceridine performed consistently in the patient population studied, including elderly and obese patients, who are at greater risk for developing opioid-related adverse effects,” said lead author, Sergio Bergese, MD, Department of Anesthesiology, School of Medicine, Stony Brook University.
In November 2018, the Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Trevena, the developer of oliceridine, rejecting the New Drug Application (NDA) and citing a need for additional data regarding the risk of QT prolongation, as well as more safety data in general. In a press release, the Company stated that they planned to resubmit the NDA sometime in the first quarter of 2020 following results of a QT study in healthy volunteers.
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