Delafloxacin

(Baxdela®)

Baxdela®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 450 mg); Injection (intravenous; 300 mg)
Drug ClassFluoroquinolone antibacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
  • Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.

Summary
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  • Delafloxacin (Baxdela) is indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), caused by designated susceptible bacteria.
  • Three studies were reviewed, which collectively analyzed data from multiple randomized controlled trials to compare delafloxacin's safety and effectiveness against other antibiotic agents in treating ABSSSI and CABP.
  • In terms of clinical efficacy, delafloxacin exhibited a comparable cure rate to comparator antibiotics such as linezolid, tigecycline, and vancomycin. For MRSA-associated ABSSSIs specifically, it showed similar clinical cure rates, underscoring its potential value in treating these challenging infections.
  • The analysis revealed no significant difference between delafloxacin's safety profile and comparative antibiotics. However, it was associated with a higher incidence of diarrhea but lower incidence of nervous system disorders, suggesting specific patient subgroups might benefit more from this drug.
  • Even though explicit mentions about population subgroups were limited within the studies; adult patients suffering from acute bacterial infections, particularly those at risk for or suffering from MRSA-associated infections, could potentially benefit most effectively from this drug.
  • Compared to other drugs like linezolid and tigecycline used in the treatment of ABSSSI, delafloxacin demonstrated non-inferiority and even showed superiority over vancomycin, making it an essential consideration due to its better tolerability highlighted by lower discontinuation rates due to adverse events.