Relyvrio: which tox species, and why?

“The pivotal (GLP-compliant) oral toxicity studies were conducted in Sprague Dawley rat and minipig (Gottingen, Hanford).”

“An additional study was initiated in beagle dog but was discontinued due to emesis, retching, tremors, loose feces, and increases in respiratory rate at all doses, including the low dose of 62.5 mg/kg PB/20.83 mg/kg TUDCA.”

“In vivo toxicology studies were conducted using AMX0035.”

“The pivotal (GLP-compliant) oral toxicity studies were conducted in Sprague Dawley rat and minipig (Gottingen, Hanford).”

“A full battery of reproductive and developmental toxicology studies was conducted for AMX0035. In the pivotal studies in CD-1 mouse and Sprague Dawley rat, AMX0035 was administered by oral gavage at doses of 0, 187.5, 375, and 750 mg/kg BID (0, 375, 750, and 1500 mg/kg/day).”

“Carcinogenicity studies have not been conducted. Carcinogenicity studies in mouse and rat may be conducted post-approval, as agreed to by the Division (Meeting Minutes, April 7, 2020, and July 22, 2021) because of the seriousness of the indication.”

“In vivo toxicology studies were conducted using AMX0035.”