Byfavo: which tox species, and why?

“In general, findings in the pivotal repeat-dose toxicity studies with the API in monkey and minipig were limited to expected pharmacology and local toxicity.”

“These two pivotal studies were selected for detailed review because the study investigated infusion dosing with the clinical formulation.”

“The repeat dose toxicity of remimazolam dosed by the intravenous route, as a bolus injection, at 5, 10 and 20 mg/kg/day once daily for 4 weeks has been conducted, including a 2-week recovery period.”

“In general, findings in the pivotal repeat-dose toxicity studies with the API in monkey and minipig were limited to expected pharmacology and local toxicity.”

“A full battery of developmental and reproductive toxicology (DART) studies for remimazolam in the rat and rabbit model were submitted in the NDA. The Applicant also conducted supplemental studies to characterize the effects of remimazolam on male reproductive tissues in minipigs.”

“Carcinogenicity studies were not conducted or required to support the safety of the proposed acute indication with remimazolam.”