Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections
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ADIS DRUG EVALUATION
Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections L. J. Scott1
© Springer Nature Switzerland AG 2020
Abstract The global spread of antibacterial-resistant strains, especially methicillin-resistant Staphylococcus aureus (MRSA) for acute bacterial skin and skin structure infections (ABSSSIs), has driven the need for novel antibacterials. Delafloxacin [Quofenix™ (EU); Baxdela® (USA)], a new fluoroquinolone (FQ), has a unique chemical structure that enhances its antibacterial activity in acidic environments such as occurs in ABSSSIs (including S. aureus infections). Delafloxacin (intravenous and oral formulations) is approved in several countries for the treatment of adults with ABSSSIs (featured indication). In intent-to-treat analyses in pivotal phase 3 trials in adults with ABSSSIs, including those with comorbid disease, intravenous delafloxacin monotherapy (± oral switch after six doses) twice daily was noninferior to intravenous vancomycin + aztreonam for primary endpoints, as specified by the FDA (objective response rate at 48–78 h after initiation of therapy) and the EMA [investigator-assessed clinical cure rate at the follow-up visit at day 14 (± 1 day)]. Delafloxacin was generally well tolerated, with most treatment-related adverse events mild to moderate in severity and few patients discontinuing treatment because of these events. Relative to vancomycin + aztreonam (a non-FQ regimen), delafloxacin treatment was not associated with an increased risk of FQ-associated AEs of special interest. Given its unique chemical structure that confers novel properties relative to other FQ and its broad spectrum of activity against common clinically relevant Gram-positive pathogens, including against MRSA strains (± FQ-resistance mutations), and Gram-negative pathogens, intravenous delafloxacin (± oral switch) provides a novel emerging option for the treatment of adult patients with ABSSSIs.
Delafloxacin: clinical considerations in acute bacterial skin and skin structure infections Novel anionic FQ, acts via equipotent targeting of the bacterial enzymes topoisomerase IV and DNA gyrase Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12218537. The manuscript was reviewed by: C. Adembri, Department of Health Sciences, Section of Anesthesiology and Critical Care, Careggi Hospital, Università di Firenze, Florence, Italy; K. C. Carroll, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; C. El Haj, Department of Infectious Disease, University Hospital Bellvitge, Barcelona, Spain; O. Murillo, Department of Infectious Disease, University Hospital Bellvitge, Barcelona, Spain; R. Zaragoza, Intensive Care Unit, University Hospital Dr Peset, Valencia, Spain.
Potent in vitro activity against a broad spectrum of relevant Gram-positive and Gram-negative bacteria, including those carrying specific resistance mutations such as MRSA (± FQ-resistant mutations) Noninferior efficacy to vancomycin pl
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