Delafloxacin

(Baxdela®)

Baxdela®

Drug updated on 12/11/2024

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 the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI)and Community-Acquired Bacterial Pneumonia (CABP)

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Delafloxacin showed no significant difference in clinical cure rate compared to other antibiotics for treating acute bacterial infections in adults, with an odds ratio (OR) of 1.06 (95% confidence interval (CI): 0.89-1.26). Its microbiological eradication rate was also similar to comparators (OR: 1.33, 95% CI: 0.94-1.88).
  • For acute bacterial skin and skin structure infections (ABSSSI), delafloxacin was non-inferior to tigecycline and linezolid, and superior to vancomycin in terms of pooled cure rates, with a pooled efficacy of 80% (95% CI: 1.01 [0.97-1.06]).
  • Delafloxacin demonstrated a safety profile similar to comparator antibiotics, with no significant differences in treatment-emergent adverse events (OR = 0.93%, 95% CI = 0.80-1.08) or serious adverse events (OR = 0.94%, 95% CI = 0.67-1.32).
  • Delafloxacin had a higher incidence of diarrhea (OR = 2.10%, 95% CI = 1.70-2.96) compared to comparators but a lower incidence of nervous system disorders (OR = 0.71%, 95% CI = 0.50-1.01).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Baxdela (delafloxacin) Prescribing Information.2021Melinta Therapeutics, LLC., Parsippany, New Jersey

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines