Sulbactam/durlobactam

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]

Sulbactam/durlobactam

Combination of
Sulbactam	beta-lactam antibacterial, beta-lactamase inhibitor
Durlobactam	beta-lactamase inhibitor
Clinical data
Trade names	Xacduro
License data	US DailyMed: Sulbactam and durlobactam
Routes of administration	Intravenous
ATC code	None
Legal status
Legal status	US: ℞-only[1]
Identifiers
KEGG	D12605

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

Legal status

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]