Ubrelvy: which tox species, and why?

“Pivotal 6- and 9-months PO studies in rat and monkey, respectively.”

“The general toxicity of orally administered ubrogepant was assessed in CD-1 mouse (3-month), Wistar rat (7- and 14-day, 1-, 3-, and 6-month), and rhesus monkey (3- and 9-month) GLP-compliant studies.”

“Pivotal 6- and 9-months PO studies in rat and monkey, respectively.”

“A standard battery of reproductive and development toxicology studies was conducted for ubrogepant: fertility and early embryonic development (0, 20, 80, and 160 mg/kg), embryofetal development (0, 1.5, 5. 25, and 125 mg/kg), and pre- and postnatal development (0, 25, 60, and 160 mg/kg) in Wistar rat, and an embryofetal development in New Zealand White rabbit”

“In adequately designed and conducted 104-week oral carcinogenicity studies in CD-1 mouse (0, 5, 15, and 50 mg/kg/day) and Wistar rat (males: 0, 10, 30, and 100 mg/kg/day; females: 0, 10, 30, and 150 mg/kg/day), ubrogepant was negative for drug-related neoplasms.”

“The general toxicity of orally administered ubrogepant was assessed in CD-1 mouse (3-month), Wistar rat (7- and 14-day, 1-, 3-, and 6-month), and rhesus monkey (3- and 9-month) GLP-compliant studies.”