Fotivda: how long were the pivotal tox studies?

“In a 39-week oral toxicity study in monkeys, the highest dose tested 0.1 mg/kg/day (HED=1.95 g/day; 1. 5-fold of the recommended human dose) was well tolerated.”

“Single-oral and intravenous (IV) dose toxicity studies in CD-1 mice and Sprague-Dawley (SD) rats were conducted followed by oral repeat-dose studies in SD rats (up to 26 weeks) and cynomolgus monkeys (up to 39 weeks).”

“The oral route was utilized in nonclinical studies as this is the intended clinical route of exposure.”