Journavx: which tox species, and why?

“The following studies were submitted: primary and secondary pharmacology, safety pharmacology in the monkey in addition to in vitro human ether-à-go-go-related gene (hERG) assays; absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK) studies; repeat-dose toxicology studies in the rat and monkey for durations of 28 days and 13 weeks”

“Based on similarities in potency against NaV1.8 and metabolic profile between monkeys and humans, monkeys were considered an appropriate species for use in the pivotal nonclinical safety studies.”

“In a 13-week monkey study, animals were treated with SUZ at 0, 20, 50, and 150 mg/kg via oral gavage.”

“repeat-dose toxicology studies in the rat and monkey for durations of 28 days and 13 weeks”

“Reproductive and developmental toxicities of SUZ were assessed in male and female fertility and early embryonic development studies in rats, embryo-fetal development (EFD) studies in rats/rabbits, and a pre- and postnatal development (PPND) study in rats.”

“Long-term animal studies have not been completed to evaluate the carcinogenic potential of suzetrigine.”

“Based on similarities in potency against NaV1.8 and metabolic profile between monkeys and humans, monkeys were considered an appropriate species for use in the pivotal nonclinical safety studies.”