Xeglyze: which tox species, and why?

“The sponsor has conducted single-dose toxicity studies in rats and repeat-dose toxicity studies in rats and minipigs.”

“These data support the use of the minipig and rat as suitable nonclinical animal models in which to assess the potential toxicity of abametapir.”

“Once daily dermal administration of abametapir lotion, 0.74% in female minipigs for 28 days was without systemic effects”

“Also the duration of treatment is much greater in the oral rat and dermal minipig studies (i.e., 14 to 28 days) compared to clinical conditions of use (single 10 minute application that is washed off).”

“Abametapir has been tested for reproductive and developmental toxicology in rats and rabbits after oral administration with no significant findings independent of maternal toxicity.”

“No carcinogenicity studies were included in this NDA submission. Abametapir lotion is intended as a single use drug product.”

“Once daily dermal administration of abametapir lotion, 0.74% in female minipigs for 28 days was without systemic effects”