Lybalvi: which tox species, and why?

“Toxicity of SAM was evaluated in Sprague-Dawley rats and Beagle dogs up to 6 months and 9 months in duration, respectively.”

“The overall pharmacokinetic profile of SAM in dogs is more closely related to humans than rats, including lack of sex difference in metabolism.”

“Toxicity of SAM was evaluated in Sprague-Dawley rats and Beagle dogs up to 6 months and 9 months in duration, respectively.”

“Toxicity of orally administered SAM was evaluated in rats and dogs up to 6-months and 9-months in duration, respectively.”

“SAM administration to pregnant rabbits during the period of organogenesis resulted in maternal toxicity, but no effects on embryofetal development at doses up to approximately 143 times MRHD based on AUC. The administration of the combination of SAM and OLZ to pregnant rats during the period of organogenesis resulted in similar effects”

“SAM is also non-carcinogenic as it did not induce tumors in male and female rats administered SAM for up to 95 weeks at exposures which are approximately 32 and 237 times the MRHD based on AUC, respectively and did not induce tumors in rasH2 transgenic mice administered SAM for 6-months.”

“Toxicity of SAM was evaluated in Sprague-Dawley rats and Beagle dogs up to 6 months and 9 months in duration, respectively.”