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]
 | |
| 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 |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
Sulbactam/durlobactam was approved for medical use in the United States in May 2023.[1][2]
Medical uses
editSulbactam/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
editThe 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
editOverall, 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
editLegal status
editSulbactam/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
edit- ^ a b c d e f "Xacduro- sulbactam and durlobactam kit". DailyMed. 2 June 2023. Retrieved 25 June 2023.
- ^ a b c d e f g h i j "FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria". U.S. Food and Drug Administration (Press release). 24 May 2023. Retrieved 24 May 2023.
This article incorporates text from this source, which is in the public domain.
- ^ 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.
- ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
External links
edit- Clinical trial number NCT03894046 for "Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (ATTACK)" at ClinicalTrials.gov
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