Recarbrio: how long were the pivotal tox studies?

“In 1- and 3-month repeated-dose toxicology studies, relebactam produced only limited toxicity.”

“The program includes repeat-dose studies up to 3 months exposure in rats and monkeys, and a repeat dose combination study with REL and imipenem/relebactam.”

“The intravenous (IV) route of administration was utilized in all toxicology studies (except in the first phase of the juvenile study in rat and the EFD study in mouse) to match the intended clinical administration route.”