Sulbactam/durlobactam

Last updated

Sulbactam/durlobactam
Sulbactam and durlobactam.svg
Combination of
Sulbactam beta-lactam antibacterial, beta-lactamase inhibitor
Durlobactam beta-lactamase inhibitor
Clinical data
Trade names Xacduro
License data
Routes of
administration 		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

Sulbactam/durlobactam, sold under the brand name Xacduro (by Innoviva Specialty Therapeutics), is a co-packaged medication used for the treatment of bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex. [1] [2] It contains sulbactam, a beta-lactam antibacterial and beta-lactamase inhibitor; and durlobactam, a beta-lactamase inhibitor. [1] [2]

Contents

Sulbactam/durlobactam was approved for medical use in the United States in May 2023. [1] [2]

Medical uses

Sulbactam/durlobactam is indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. [1] [2]

History

The efficacy of sulbactam/durlobactam was established in a multicenter, active-controlled, open-label (investigator-unblinded, assessor-blinded), non-inferiority clinical trial in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii. [2] Participants received either sulbactam/durlobactam or colistin (a comparator antibiotic) for up to 14 days. [2] Both treatment arms also received an additional antibiotic, imipenem/cilastatin, as background therapy for potential hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia pathogens other than Acinetobacter baumannii-calcoaceticus complex. [2] The primary measure of efficacy was mortality from all causes within 28 days of treatment in participants with a confirmed infection with carbapenem-resistant A. baumannii. [2] Of those who received sulbactam/durlobactam, 19% (12 of 63 participants) died, compared to 32% (20 of 62 participants) who received colistin; this demonstrated that sulbactam/durlobactam was noninferior to colistin. [2]

Resistances

Overall, 2.3% of Acinetobacter baumannii strains are resistant to sulbactam/durlobactam. This percentage increases to 3.4% and 3.7% in the subgroups of carbapenem-resistant and colistin-resistant Acinetobacter, respectively. In Acinetobacter strains producing metallo-beta-lactamases, sulbactam/durlobactam resistance is 100%. [3]

Society and culture

Sulbactam/durlobactam was approved for medical use in the United States in May 2023. [1] [2] The FDA granted the application for sulbactam/durlobactam fast track and priority review designations. [4]

References

  1. 1 2 3 4 5 6 "Xacduro- sulbactam and durlobactam kit". DailyMed. 2 June 2023. Retrieved 25 June 2023.
  2. 1 2 3 4 5 6 7 8 9 10 "FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria". U.S. Food and Drug Administration (Press release). 24 May 2023. Archived from the original on 23 May 2023. Retrieved 24 May 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ Principe L, Di Bella S, Conti J, Perilli M, Piccirilli A, Mussini C, et al. (December 2022). "Acinetobacter baumannii Resistance to Sulbactam/Durlobactam: A Systematic Review". Antibiotics. 11 (12): 1793. doi: 10.3390/antibiotics11121793 . PMC   9774100 . PMID   36551450.
  4. ↑ New Drug Therapy Approvals 2023. U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original (PDF) on 10 January 2024. Retrieved 9 January 2024.


This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.