Abuse potential of mirogabalin in recreational polydrug users

Mirogabalin is a selective calcium channel α(2)δ subunit ligand being developed to treat neuropathic pain. In accordance with US Food and Drug Administration (FDA) guidance, the human abuse potential of mirogabalin (15–105 mg) was examined, relative to placebo, diazepam (15 or 30 mg), and pregabalin (200 or 450 mg), in two single-dose, randomized, double-blind, placebo- and active-controlled crossover studies in recreational polydrug users who could discern between positive comparator and placebo. The primary endpoint was maximum observed effect (E(max)) for Drug Liking Visual Analog Scale. At therapeutic doses, mirogabalin Drug Liking E(max) did not differ significantly from placebo and was significantly lower than diazepam and pregabalin. This indicates therapeutic doses mirogabalin may have less abuse potential versus diazepam or pregabalin. At supratherapeutic doses (⩾4× therapeutic dose), mirogabalin had significantly higher Drug Liking E(max) than placebo, but lower E(max) than pregabalin. In both studies, therapeutic doses of mirogabalin demonstrated limited evidence of abuse potential.