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

<jats:title>Abstract</jats:title><jats:sec><jats:title>Aims/Introduction</jats:title><jats:p>This study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α<jats:sub>2</jats:sub>δ subunit of voltage‐dependent Ca<jats:sup>2+</jats:sup> channels, for the treatment of diabetic peripheral neuropathic pain (<jats:styled-content style="fixed-case">DPNP</jats:styled-content>).</jats:p></jats:sec><jats:sec><jats:title>Materials and Methods</jats:title><jats:p>During this double‐blind, multisite, placebo‐controlled phase III study, Asian patients aged ≥20 years with type 1 or 2 diabetes and <jats:styled-content style="fixed-case">DPNP</jats:styled-content> 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 (<jats:styled-content style="fixed-case">NCT</jats:styled-content>02318706). The primary endpoint was the change from baseline in average daily pain score (<jats:styled-content style="fixed-case">ADPS</jats:styled-content>) at week 14, defined as a weekly average of daily pain (0 = no pain to 10 = worst possible pain, for the past 24 h).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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, <jats:italic>n</jats:italic> = 824); 755 (90.5%) completed the study. At week 14, the least squares mean <jats:styled-content style="fixed-case">average daily pain score</jats:styled-content> change from baseline was −1.31, −1.34, −1.47 and −1.81, respectively, showing statistical significance for mirogabalin 30 mg/day versus placebo (<jats:italic>P </jats:italic>=<jats:italic> </jats:italic>0.0027). The treatment‐emergent adverse events observed were mostly mild‐to‐moderate in all mirogabalin doses, and the most frequent <jats:styled-content style="fixed-case">treatment‐emergent adverse events</jats:styled-content> were nasopharyngitis, somnolence, dizziness, peripheral edema and weight increase.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Mirogabalin relieved <jats:styled-content style="fixed-case">DPNP</jats:styled-content> in a dose‐dependent manner; mirogabalin 30 mg/day showed statistically significant pain relief (vs placebo) in Asian <jats:styled-content style="fixed-case">DPNP</jats:styled-content> patients. All doses of mirogabalin tested were well tolerated.</jats:p></jats:sec>