Studies on articular and general toxicity of orally administered ozenoxacin in juvenile rats and dogs.

Abstract

Ozenoxacin is a nonfluorinated quinolone antibacterial approved for topical treatment of impetigo. Because quinolones have known chondrotoxic effects in juvenile animals, the potential toxicity of ozenoxacin was assessed in preclinical studies. Ozenoxacin or ofloxacin (300mg/kg/day for 5days, for each compound) was orally administered to juvenile rats, and oral ozenoxacin (10-100mg/kg/day for 14days) was administered to juvenile dogs. In juvenile rats, ozenoxacin showed no chondrotoxicity, whereas ofloxacin produced typical quinolone-induced lesions in articular cartilage in three of ten rats. Oral ozenoxacin administration to juvenile dogs showed no chondrotoxicity or toxicologically relevant findings in selected target organs. Ozenoxacin was generally well-tolerated in juvenile rats and dogs, with no evidence of quinolone-induced arthropathy.