Journal
REPRODUCTIVE TOXICOLOGY
Volume 52, Issue -, Pages 18-25Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.reprotox.2014.12.007
Keywords
Efinaconazole; Embryolethal; Triazole; Antifungal; Propylene glycol; CYP51; Lanosterol 14 alpha demethylase
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Efinaconazole is a new triazole antifungal for topical treatment of onychomycosis. The reproductive and developmental toxicity of efinaconazole was characterized in fertility and early embryonic development (rat), embryo-fetal development (rat and rabbit), and pen/post-natal development (rat) studies in accordance with current ICH guidances. In the fertility study, maternal reproductive toxicity was noted as estrous cycle prolongation (NOAEL=5 mg/kg/day) but there were no male reproductive effects even in the presence of paternal toxicity (NOAEL=25 mg/kg/day). Rat embryo-fetal and pennatal pup lethality was the most sensitive (NOAEL=5 mg/kg/day) efinaconazole developmental toxicity and was noted at maternally toxic doses. Efinaconazole did not affect rabbit embryo-fetal development at maternally toxic doses (NOAEL=10 mg/kg/day). No malformations were induced by efinaconazole in rats or rabbits. When compared with systemic exposures observed in onychomycosis patients, embryo-fetal toxicity in rats was noted at high (>100-fold) multiples of systemic exposure. (C) 2015 The Authors. Published by Elsevier Inc.
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