Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections

Area of Science:

• Infectious Diseases
• Pharmacology
• Dermatology

Background:

• Rising antibacterial resistance, particularly methicillin-resistant Staphylococcus aureus (MRSA), necessitates novel treatments for acute bacterial skin and skin structure infections (ABSSSIs).
• Delafloxacin, a novel fluoroquinolone (FQ), exhibits enhanced activity in acidic environments characteristic of ABSSSIs.

Purpose of the Study:

• To evaluate the efficacy and safety of delafloxacin for treating adult ABSSSIs.
• To compare delafloxacin's outcomes against a standard non-FQ regimen.

Main Methods:

• Pivotal Phase 3 trials involving adult ABSSSIs patients, including those with comorbidities.
• Intent-to-treat analyses comparing intravenous delafloxacin (± oral switch) to intravenous vancomycin + aztreonam.

Main Results:

• Delafloxacin demonstrated non-inferiority to vancomycin + aztreonam for primary efficacy endpoints (FDA and EMA specified).
• Delafloxacin was well-tolerated, with mild to moderate adverse events and low discontinuation rates.
• No increased risk of FQ-associated adverse events of special interest was observed compared to the control.

Conclusions:

• Intravenous delafloxacin, with or without an oral switch, is a viable treatment option for adult ABSSSIs.
• Its unique properties and broad-spectrum activity against Gram-positive (including MRSA) and Gram-negative pathogens make it a valuable addition to the therapeutic arsenal.