Xeglyze: genotox, carcinogenicity and repro: done or skipped?

“Abametapir and abametapir-COOH, the major human metabolite, were not mutagenic in the Ames test. Abametapir caused increases in chromosome aberrations in Human lymphocytes but only at cytotoxic concentrations and was negative in the in vivo rat micronucleus assay”

“Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of XEGLYZE or abametapir.”

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

“Inhibitory effects on the hERG current raised concerns about QTc prolongation (IC50 =~56 µM ).”

“Abametapir and abametapir-COOH, the major human metabolite, were not mutagenic in the Ames test.”

“In the in vitro chromosomal aberration test in Human lymphocytes, chromosomal aberrations were observed, but only at cytotoxic concentrations ( 230.3 µg/mL). This result was considered equivocal.”

“Abametapir (<160 mg/kg/day) did not induce micronucleus formation in the in vivo rat micronucleus assay.”

“Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of XEGLYZE or abametapir.”

“No carcinogenicity studies were included in this NDA submission. Abametapir lotion is intended as a single use drug product. Re-infestation would require a second application, but the product is not intended for chronic use.”

“Inhibitory effects on the hERG current raised concerns about QTc prolongation (IC50 =~56 µM ).”