September 23, 2015

Finafloxacin More Effective Than Ciprofloxacin for Complicated UTIs

SAN DIEGO -- September 23, 2015 -- Results from a double-blind phase 2 study showed that finafloxacin was a more effective and safe option than ciprofloxacin for the treatment of complicated urinary tract infections (UTIs) and acute pyelonephritis.

The findings were presented at the 2015 Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Data from the study showed that patients treated with a 5-day course of finafloxacin had a higher, more rapid, and more sustained level of pathogen eradication and improved clinical outcomes than those treated with the current standard of care (ciprofloxacin twice daily for 10 days).

“Finafloxacin was found to be both safe and tolerable and could offer physician a viable additional option when treating bacterial infections in future,” said David Dally, MerLion Pharmaceuticals Pte. Ltd., Singapore.

For the study, 225 adult patients diagnosed with complicated UTIs and acute pyelonephritis at 18 sites in Poland and Germany were randomised to receive finafloxacin 800 mg once daily either for a total of 5 or 10 days or ciprofloxacin 400 mg (oral)/500 mg (IV) twice daily for 10 days. Physicians could switch from the initial intravenous to oral administration and release the patients from hospital after day 3.

Finafloxacin dosed for 5 days was as efficient as finafloxacin dosed for 10 days in a combined evaluation of the clinical and microbiological response with efficacy rates of 70% and 68% on day 17 of the study.

Both finafloxacin dosing regimens were more efficient than the treatment with ciprofloxacin for 10 days resulting in 57% efficacy.

The short 5-day treatment period with finafloxacin did not result in an increased rate of relapses when compared with both 10-day treatment regimens in the study.

Furthermore, an interim evaluation on day 3 of the study revealed that finafloxacin eradicated pathogens more quickly than ciprofloxacin (89% vs 79%). This rapid antibacterial activity of finafloxacin was not affected by urine pH, with comparable activity at acidic, neutral, and basic conditions, whereas ciprofloxacin eradicated pathogens less efficiently in patients with acidic urine.

“In contrast to ciprofloxacin, finafloxacin also showed a very rapid antimicrobial effect against ciprofloxacin-resistant pathogens and ESBL producing bacteria,” said Dally.

SOURCE: American Society for Microbiology
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