Merlion Pharmaceuticals Pte. Ltd.

Carsten Fischer

Andreas Vente

Sven-Eric Wohlert

Mark Lückermann

Christine Bentley

It was found that finafloxacin has a high solubility in the presence of Tris. Such solubility is significantly higher than in the presence of other compounds typically used as buffers (e.g. phosphate buffer). The observed significant increase in solubility of finafloxacin in compositions comprising Tris is further advantageously accompanied by a long term stability of such solutions. Tris is therefore to be regarded as a specific tool to considerably enhance the solubility of finafloxacin in solutions. By preparing compositions comprising Tris it is possible to dissolve finafloxacin in such an amount therein that these compositions can effectively be used as parenteral compositions for the treatment of bacterial infections.

Compositions comprising finafloxacin and Tris

It was found that finafloxacin eradicates pathogens from patients suffering from bacterial infections like urinary tract infections and pyelonephritis more quickly than other fluoroquinolones regularly used for the treatment of these patients. Due to the efficacy of finafloxacin reduced treatment durations without increasing the daily dosage of finafloxacin and at the same time no or shorter stays in hospital are realizable, thus improving patient convenience and significantly lowering the costs of hospitalization and treatment. Reduced hospitalization periods do also clearly reduce the risk of nosocomial infections and of generating drug-resistant strains through extended therapy. The inventive treatment regimens comprise an oral finafloxacin administration for 1-5 days or a parenteral finafloxacin administration for 1-5 days for use in the treatment of a complicated urinary tract infection or pyelonephritis. However, a prior short parenteral administration of finafloxacin (e.g. 3 days) in combination with an oral administration (e.g. 2 days) may be applied, if necessary in case of really severe infections. The present invention further relates to a novel treatment regime for the treatment of uncomplicated UTI whereby a single oral finafloxacin dose is considered to be sufficient to effectively treat patients with uncomplicated UTI.

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Berlin, Germany

Carsten Fischer