Preclinical safety evaluation of moxifloxacin, a novel fluoroquinolone

The toxicity of moxifloxacin (BAY 12-8039), a novel fluoroquinolone with a broad spectrum of antibacterial activity, was evaluated in a comprehensive programme of toxicological studies that included single and multiple dose t oxicity studies in rats, mice, dogs and monkeys, reproductive system toxici ty studies in rats and monkeys and in-vitro and in-vivo mutagenicity assays , Although moxifloxacin is not intended for long-term clinical use, an acce lerated bioassay in target organs to assess carcinogenesis was performed in rats. In addition to the routine toxicological programme required for the development of a drug intended for shortterm administration, a major part o f the preclinical programme for moxifloxacin comprised studies designed spe cifically to address the safety issues known to be features of fluoroquinol ones, i.e. adverse effects on the central nervous and cardiovascular system s, phototoxicity, arthrotoxicity and oculotoxicity. The results of the toxi cological investigations confirmed that the safety profile of moxifloxacin is comparable to those of other fluoroquinolones.