Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double‐blind, placebo‐controlled phase III study in Asian patients

AIMS/INTRODUCTION: This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α(2)δ subunit of voltage‐dependent Ca(2+) channels, for the treatment of diabetic peripheral neuropathic pain (DPNP). MATERIALS AND METHODS: During this double‐blind, multisite, placebo‐controlled phase III study, Asian patients aged ≥20 years with type 1 or 2 diabetes and DPNP were randomized 2:1:1:1 to a placebo, mirogabalin 15, 20 or 30 mg/day for up to 14 weeks, with a 1‐ to 2‐week titration (NCT02318706). The primary endpoint was the change from baseline in average daily pain score (ADPS) at week 14, defined as a weekly average of daily pain (0 = no pain to 10 = worst possible pain, for the past 24 h). RESULTS: Of 834 randomized patients, 330, 164, 165 and 165 received placebo, mirogabalin 15, 20 or 30 mg/day, respectively, and were included in analyses (modified intention‐to‐treat population, n = 824); 755 (90.5%) completed the study. At week 14, the least squares mean average daily pain score change from baseline was −1.31, −1.34, −1.47 and −1.81, respectively, showing statistical significance for mirogabalin 30 mg/day versus placebo (P = 0.0027). The treatment‐emergent adverse events observed were mostly mild‐to‐moderate in all mirogabalin doses, and the most frequent treatment‐emergent adverse events were nasopharyngitis, somnolence, dizziness, peripheral edema and weight increase. CONCLUSIONS: Mirogabalin relieved DPNP in a dose‐dependent manner; mirogabalin 30 mg/day showed statistically significant pain relief (vs placebo) in Asian DPNP patients. All doses of mirogabalin tested were well tolerated.