Defencath: which tox species, and why?

“A single dose intraperitoneal study conducted with Defencath in mice and a 14-day repeat-dose intravenous study conducted in rats (discussed in additional detail below) did not reveal signs of toxicity.”

“However, the medical reviewers found that previous clinical experience with taurolidine (particularly as a component of CLS) was adequate to support the clinical development of Defencath and the toxicology reviewer deferred to their judgement.”

“A diluted solution of Defencath did not cause toxicity in rats when administered intravenously daily for 14 days.”

“A single dose intraperitoneal study conducted with Defencath in mice and a 14-day repeat-dose intravenous study conducted in rats (discussed in additional detail below) did not reveal signs of toxicity.”

“Reproductive and developmental toxicology studies were waived for Defencath because the product is not intended for systemic administration and clinical exposure to its components is negligible when used as directed.”

“Carcinogenicity studies were not needed for Defencath because the product is not intended for systemic administration and clinical exposure to its components is negligible when used as directed.”

“A diluted solution of Defencath did not cause toxicity in rats when administered intravenously daily for 14 days.”