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.”

“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.”

“Embryofoetal toxicity of pitolisant was evaluated in rats and rabbits following administration during the organogenesis period.”

“A two-year carcinogenicity study of pitolisant was conducted in rats and a 6-month carcinogenicity study was conducted in tgRasH2 mice. The executive carcinogenicity assessment committee concluded that these studies were adequate and that there were no drug-related neoplasms in either study.”

“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.”