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Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections
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 (...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497496/ https://www.ncbi.nlm.nih.gov/pubmed/32666425 http://dx.doi.org/10.1007/s40265-020-01358-0 |
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author | Scott, L. J. |
author_facet | Scott, L. J. |
author_sort | Scott, L. J. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7497496 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-74974962020-10-13 Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections Scott, L. J. Drugs Adis Drug Evaluation 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. Springer International Publishing 2020-09-15 2020 /pmc/articles/PMC7497496/ /pubmed/32666425 http://dx.doi.org/10.1007/s40265-020-01358-0 Text en © Springer Nature 2020, corrected publication September 2020 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Adis Drug Evaluation Scott, L. J. Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections |
title | Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections |
title_full | Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections |
title_fullStr | Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections |
title_full_unstemmed | Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections |
title_short | Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections |
title_sort | delafloxacin: a review in acute bacterial skin and skin structure infections |
topic | Adis Drug Evaluation |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497496/ https://www.ncbi.nlm.nih.gov/pubmed/32666425 http://dx.doi.org/10.1007/s40265-020-01358-0 |
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