Wakix: which tox species, and why?

“Single and Repeat dose toxicity studies were conducted in mice, rats, and monkeys up to 1-month, 6-month and 9-month in duration, respectively.”

“From the comparison of metabolites formed in vivo in Cynomolgus monkeys and in humans, the applicant did conclude that Cynomolgus monkeys could be used as the non-rodent species for toxicity studies.”

“Single and Repeat dose toxicity studies were conducted in mice, rats, and monkeys up to 1-month, 6-month and 9-month in duration, respectively.”