Efficacy and safety of mirogabalin + opioids vs opioids alone for neuropathic cancer pain: Miro-Canp

Opioids are a treatment for cancer pain, but may be less effective for neuropathic than nociceptive pain. However, evidence supporting opioid – neuropathic drug combinations for neuropathic cancer pain (NCP) remains limited. This randomized, open-label, parallel-group study, conducted across Japan, evaluated the efficacy and safety of mirogabalin + opioids (M+O) versus opioid monotherapy (O) in patients with NCP. Change in the numerical rating scale (NRS) pain score from baseline at Week 4 was the primary endpoint. Of 142 patients, 141 were randomized (M+O, N = 71; O, N = 70). The M+O group achieved a greater reduction in NRS pain scores from baseline at Week 4 than the O group (intergroup difference in least squares mean changes: −1.5, 95% confidence interval: −2.4, −0.6; P = 0.0017) and higher NRS responder (≥30% reduction) rates (72.3% vs. 42.0%; P = 0.0039). Treatment-emergent adverse event incidences were 60.9% (42/69) and 27.1% (19/70) in the M+O and O groups, respectively. Somnolence (20.3%) and dizziness (8.7%) were the most common adverse drug events for mirogabalin. Mirogabalin, as an opioid add-on, improved neuropathic pain vs opioid monotherapy in patients with NCP. Concomitant use of mirogabalin could be a novel treatment option for NCP. Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/) identifier is jRCTs031220569.