Barhemsys: how long were the pivotal tox studies?

“In support of the safety of amisulpride, the applicant submitted the following nonclinical studies: pharmacodynamic studies, a 4-week repeat-dose IV toxicity study in rats, and a battery of genotoxicity and reproductive and developmental toxicity studies.”

“Study title/number: Amisulpride: Intravenous (Slow Bolus) 28-Day Toxicity Study in the Rat with a 14 Day Treatment Free Period (Study # BGX0002).”

“amisulpride was administered IV to Charles River Wistar (Crl:WI(Han)) rats at doses of 0, 2, 5 and 10 mg/kg/day.”