“In the 39-week study, the high dose was reduced to 40 mg/kg/day because of intolerability.”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Pivotal GLP studies
26-week rat and 39-week dog oral studies
“General Toxicology: the oral toxicity of lasmiditan was tested in Sprague-Dawley rat (4-week + 2-week recovery, 13-week + 4-week recovery, and 26-week + 8-week recovery) and Beagle dog (2-week, 4-week + 2-week recovery, 13-week + 4-week recovery, and 39-week + 8-week recovery).”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Route in tox
Oral
“All pivotal in vivo nonclinical studies were conducted using oral administration.”
✓ VerifiedFDA pharmacology/toxicology review, p. 11Source ↗