What is the role of delafloxacin in intravenous-to-oral switch therapy?

Updated: Jul 30, 2018
  • Author: Shirin A Mazumder, MD; Chief Editor: Pranatharthi Haran Chandrasekar, MBBS, MD  more...
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Answer

Answer

In June 2017, FDA approved Baxdela (delafloxacin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Approvals for delafloxacin were supported by two phase III studies in patients with ABSSSI demonstrating that IV and oral delafloxacin monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48–72 hours [104] . [105]

Baxdela exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations. The oral bioavailability is 58.8%, with 450 mg taken orally being equivalent to IV infusion of 300 mg for 1 h, permitting oral sequencing.   Delafloxacin is excreted renally and unaffected by cytochrome P450. The recommended dosage for IV use is 300 mg every 12 h, and orally, 450 mg every 12 h. [103]


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