Delafloxacin is an anionic fluoroquinolone (FQ) antibiotic, with a good safety profile, active against both Gram positive and negative bacteria, including Methicillin-resistant Staph. aureus (MRSA) and FQs resistant strains.
Based on the clinical results, delafloxacin could be an excellent treatment option for patients with comorbidities, at higher risk of infections by difficult-to-treat microorganisms, like MRSA and multi resistant Gram negative strains, which cause recurrent infections, poor patient outcomes and higher use of healthcare resources.
During the clinical development, delafloxacin demonstrated a good safety and tolerability profile, with improved characteristics in comparison to other antibiotics of this class (absence of QT-prolongation and phototoxicity).
In 2018, a marketing authorization application for the first indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) has been submitted to EMA and a global phase III registrational study in hospitalized patients with Community Acquired Bacterial Pneumonia (CABP) has been completed.
To date, the clinical development of delafloxacin includes a phase IIIb clinical trial in ABSSSI started in 2019 and involving about 70 European clinical centers.
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