Nurtec ODT: which tox species, and why?

“Oral toxicology studies of up to 6 and 9 months’ duration were conducted in Sprague Dawley (SD) rat and cynomolgus monkey, respectively.”

“Comparing activity across species, rimegepant exhibits similar receptor affinities at both human (Ki of 33 pM) and nonhuman primate (marmoset (92 pM) and cynomolgus monkey (60 pM)) CGRP receptors, with more than 1,300-fold less activity at dog (43 nM), rat (209 nM) and mouse (104 nM) CGRP receptors as compared to human.”

“Doses of 0, 5, 15, and 50 mg/kg were evaluated in the pivotal 9-month study; there were no adverse findings. The NOAEL for orally-administered rimegepant in monkey was 50 mg/kg.”

“Oral toxicology studies of up to 6 and 9 months’ duration were conducted in Sprague Dawley (SD) rat and cynomolgus monkey, respectively.”

“Reproductive toxicity studies conducted and rats and rabbits were considered adequate for assessment of possible rimegepant-induced effects on reproduction.”

“The carcinogenic potential of rimegepant was assessed in a 26-week study in Tg.rasH2 mouse (0, 10, 100, or 300 mg/kg/day) and a lifetime study in Sprague-Dawley rat (0, 5, 20, or 45 mg/kg/day).”