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

“It was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or clastogenic in the in vitro mammalian chromosomal aberration assay (human peripheral blood) or the in vivo rat bone marrow micronucleus assay.”

“Viloxazine did not increase the incidence of tumors in rats treated for 2 years at oral doses of 22, 43, and 87 mg/kg/day. The high dose of 87 mg/kg/day is approximately equal to the MRHD of 600 mg in adults, based on mg/m 2 . Viloxazine did not increase the incidence of tumors in Tg.rasH2 mice treated for 26 weeks at oral doses of 4.3, 13, and 43 mg/kg/day.”

“However, at a dose of 82 mg/kg/day, viloxazine increased early and late resorptions, delayed fetal development, and caused low incidences of fetal malformations or anomalies (craniorachischisis, missing cervical vertebrae, and morphological changes associated with hydranencephaly).”

“In telemetry-instrumented male conscious dogs (Study 809V-Tox2007-031, GLP), after a single oral dose (capsule) of viloxazine at 0 (control, empty capsule), 5, 25, and 50 mg/kg (n=4, Latin square design) there were no drug-related changes in ECG (PR, QRS, QT, or QTcF) or blood pressure”