Sunosi: which tox species, and why?

“Pivotal repeat-dose toxicity studies have been performed in mice (up to 3 months), rats (up to 6 months with a 3-month recovery period) and dogs (up to 12 months with a 13 weeks recovery period).”

“The in vivo metabolism profiles of solriamfetol are similar between dogs and humans, for which limited hepatic metabolism is observed and the majority of the drug is excreted unchanged in the urine.”

“Rats: In a pivotal 6-month repeat-dose toxicity study with a 3-month recovery period, daily oral doses of 29, 253 and 505 (reduced to 379 at study day 93 because of overt toxicity) mg/kg solriamfetol produced”