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

“Solriamfetol was non-genotoxic in an adequate battery of genotoxicity assays.”

“Solriamfetol was not carcinogenic and did not induce tumors in rats or mice when administered orally at doses up to approximately 3.5- and 9- times the MRHD of 300 mg/day to rats and mice, respectively, based on AUC.”

“In embryo-fetal developmental studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 2- and 2.5- times- and was teratogenic at doses 9.5- and ≥ 2.5- times, respectively, the MRHD”

“The safety pharmacology of solriamfetol was evaluated in the cardiovascular, respiratory, and CNS systems. No severe adverse effects were identified at the clinically relevant doses.”