Ztalmy: how long were the pivotal tox studies?

“In the 12-month dog study (1245-011; oral doses of 0, 3, 10, or 15 mg/kg/day, preformulated suspension), dose-dependent clinical findings related to the sedative effect (decreased activity, tremors, ataxia, prostration, and unresponsiveness) were seen at all doses.”

“The primary drug-related toxicity observed in the general toxicology studies of duration up to 6 and 12 months in Sprague Dawley (SD) rat and beagle dog, respectively, was sedation, which in some cases was associated with death or premature sacrifice.”

“In the second stage of development, a new formulation - not containing β-CD - was evaluated in repeat-dose toxicology studies in mice (2 weeks, dosing up to 1000 mg/kg/day), in rats (4 weeks, dosing up to 80 mg/kg/day) and in dogs (up to 12 months, dosing up to 15 mg/kg/day) using a preformulated oral GNX suspension.”