Innoviva Specialty Therapeutics, a subsidiary of Innoviva, has introduced XACDURO® (sulbactam for injection; durlobactam for injection) to the U.S. market, making it available for individuals aged 18 and above. This antibiotic is uniquely tailored for addressing hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) triggered by Acinetobacter, a formidable, antibiotic-resistant pathogen linked to elevated rates of illness and mortality.
XACDURO stands out for its precise targeting of Acinetobacter, marking a significant breakthrough in the treatment of these severe infections. Clinical trials have demonstrated XACDURO's statistical non-inferiority when compared to colistin concerning the primary endpoint of 28-day all-cause mortality among patients with carbapenem-resistant Acinetobacter infections. Furthermore, it has exhibited a favorable safety profile and a reduced incidence of nephrotoxicity. Notably, XACDURO resulted in fewer serious adverse events and fewer instances of treatment discontinuation due to adverse reactions in comparison to colistin, with only one patient experiencing anaphylactic shock, leading to treatment discontinuation in that specific case.
Acinetobacter infections present a pressing global challenge, particularly for patients on ventilators within healthcare facilities. This pathogen has progressively developed resistance to most commonly used antibiotics for treating HABP and VABP, rendering the development of a standardized treatment regimen unattainable.
XACDURO comprises sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, co-packaged for intravenous administration. It is exclusively approved for patients aged 18 and above for the explicit treatment of HABP/VABP caused by susceptible strains of Acinetobacter, with no indication for infections caused by other pathogens.