Delafloxacin: A Review in Community-Acquired Pneumonia

Drugs. 2022 Jun;82(8):913-923. doi: 10.1007/s40265-022-01725-z. Epub 2022 Jun 16.

Abstract

Delafloxacin (BAXDELA® in the USA; Quofenix® in the EU) is an anionic fluoroquinolone antibacterial that is approved for the treatment of community-acquired pneumonia (CAP) and acute bacterial skin and skin structure infections in adults. Delafloxacin demonstrated in vitro activity against Gram-positive and Gram-negative pathogens, including drug-resistant isolates. In a phase III trial in adults with CAP, delafloxacin was noninferior to moxifloxacin when assessed against FDA- and EMA-defined primary endpoints, with both fluoroquinolones achieving high treatment success rates. A prespecified subgroup analysis suggested that delafloxacin may be more efficacious than moxifloxacin in patients with a history of asthma or chronic obstructive pulmonary disease (COPD). Delafloxacin was generally well tolerated in patients with CAP, with most treatment-emergent adverse events graded as mild or moderate in severity. Fluoroquinolone-associated adverse events of special interest occurred infrequently, with no events of QT prolongation or phototoxicity reported with delafloxacin. Delafloxacin is an effective and generally well-tolerated treatment that increases the number of available treatments for CAP and, although further research is required, may be a useful option for patients with CAP and comorbid asthma or COPD.

Plain language summary

Community-acquired pneumonia (CAP) can be caused by bacterial infection of the lungs, and is a common cause of infection-related deaths. As drug-resistant bacteria are becoming more common, new antibacterial drugs are needed. Delafloxacin (BAXDELA® in the USA; Quofenix® in the EU) is a fluoroquinolone antibacterial that inhibits bacterial enzymes required for DNA repair and replication. Delafloxacin kills a wide range of bacteria, including some drug-resistant variants. During a trial in adults with CAP, delafloxacin was as effective as moxifloxacin (also a fluoroquinolone antibacterial). Delafloxacin may be more effective than moxifloxacin in patients with a history of asthma or chronic obstructive pulmonary disease (COPD), although further research is needed. Most adverse events with delafloxacin were mild or moderate in severity, with diarrhoea being the most commonly occurring treatment-related adverse event (experienced by < 4% of recipients). Furthermore, the adverse effects of delafloxacin were generally consistent with those previously observed in patients with skin infections. Delafloxacin expands the range of treatments for CAP, and is potentially useful for patients with comorbid asthma or COPD.

Publication types

  • Review

MeSH terms

  • Adult
  • Anti-Bacterial Agents / adverse effects
  • Asthma* / drug therapy
  • Community-Acquired Infections* / drug therapy
  • Community-Acquired Infections* / microbiology
  • Fluoroquinolones / adverse effects
  • Humans
  • Moxifloxacin / therapeutic use
  • Pneumonia* / drug therapy
  • Pulmonary Disease, Chronic Obstructive* / drug therapy

Substances

  • Anti-Bacterial Agents
  • Fluoroquinolones
  • delafloxacin
  • Moxifloxacin