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Abuse potential of mirogabalin in recreational polydrug users
Mirogabalin is a selective calcium channel α 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 (...
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Published in: | Therapeutic advances in drug safety 2019, Vol.10, p.2042098619836032-2042098619836032 |
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Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | Mirogabalin is a selective calcium channel α
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 (
) for Drug Liking Visual Analog Scale. At therapeutic doses, mirogabalin Drug Liking
did not differ significantly from placebo and was significantly lower than diazepam and pregabalin. This indicates therapeutic doses mirogabalin may have less abuse potential
diazepam or pregabalin. At supratherapeutic doses (⩾4× therapeutic dose), mirogabalin had significantly higher Drug Liking
than placebo, but lower
than pregabalin. In both studies, therapeutic doses of mirogabalin demonstrated limited evidence of abuse potential. |
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ISSN: | 2042-0986 2042-0994 |
DOI: | 10.1177/2042098619836032 |