Basic and clinical studies on NM441 in chronic bacterial prostatitis

We performed basic and clinical studies of NM441, a new quinolone antibiotic, in chronic bacterial prostatitis, and the following results were obtained. 1. Basic study: 1) Human prostatic tissue concentrations: Concentrations in the prostatic tissue (Mean) were 1.72, 1.20, 1.25, 1.29, 1.17, 0.52 and 0.38μg/g, and the serum concentrations (Mean) were 1.42, 0.40, 0.28, 0.42, 0.36, 0.19 and 0.06μg/ml at 1.5, 2, 2.5, 4, 6, 8 and 24h after 200mg of NM441 administration, respectively. The ratios of the concentrations of prostatic tissue and serum were 0.71 to 13.0. 2) Human prostatic fluid concentrations: Concentrations in the prostatic fluid were < 0.01 to 0.44μg/ml at 1h after 200mg of NM441 administration, and mean concentrations were 0.05, 0.02 and 0.14μg/ml at 1.5, 2 and 4h after administration, respectively. The serum concentrations (Mean) were 0.50, 0.73, 0.80 and 0.28μg/ml at 1, 1.5, 2, and 4h after administration, respectively. The ratios of the concentrations of prostatic fluid and serum were 0.02 to 1.62. 2. Clinical study: NM441 was orally administered to 22 patients with chronic bacterial prostatitis at a dose of 200mg twice a day for 10~22 days (Mean: 14.3 days). The clinical efficacy rate was 76.5% in 17 patients evaluable according to the criteria of the Japanese UTI Committee. Side effects were observed in a total of 2 cases; stomach discomfort and heartburn in 1, and oral cavity discomfort in 1, but all were mild and the treatment was continued. An abnormal laboratory finding was observed eosinophilia in 1 case, but this case recovered at 8 days after the termination of administration.