Zurzuvae: how long were the pivotal tox studies?

“In the pivotal 9-month study in dogs (0, 0.6, 1.2 and 2.5 mg/kg), sedation, sedation-related clinical signs (impaired equilibrium, hypoactivity, ataxia, tremors, and being prostrate) and increased heart rate and mortality were observed.”

“Dose selection for the 6- and 9-month toxicology studies in rat and dog was based on the results of shorter-duration studies that identified clear dose-limiting toxicity, including premature death and adverse clinical signs (e.g., sedation, convulsions).”

“The toxicological assessment is based on in single and repeated dose oral (gavage) toxicity studies in rats and dogs, in vitro and in vivo genotoxicity tests, reproduction and developmental toxicity studies in rabbits and/or rats, juvenile toxicity studies using rats, carcinogenicity studies in rats and transgenic mice, and studies to assess abuse liability and dependence potential.”