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. It contains

sulbactam Sulbactam is a β-lactamase inhibitor. This drug is given in combination with β-lactam antibiotics to inhibit β-lactamase, an enzyme produced by bacteria that destroys the antibiotic An antibiotic is a type of antimicrobial substance ac ...

, a beta-lactam antibacterial and

beta-lactamase inhibitor Beta-lactamases (β-lactamases) are enzymes () produced by bacteria that provide multi-resistance to beta-lactam antibiotics such as penicillins, cephalosporins, cephamycins, monobactams and carbapenems (ertapenem), although carbapenems ...

; and

durlobactam Durlobactam is a beta-lactamase inhibitor used in combination with sulbactam to treat susceptible strains of bacteria in the genus ''Acinetobacter'' It is an analog of avibactam. The combination therapy sulbactam/durlobactam Sulbactam/dur ...

, a beta-lactamase inhibitor. Sulbactam/durlobactam was approved for medical use in the United States in May 2023.

Medical uses

Sulbactam/durlobactam is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of ''Acinetobacter baumannii-calcoaceticus'' complex.

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''. Participants received either sulbactam/durlobactam or

colistin Colistin, also known as polymyxin E, is an antibiotic medication used as a last-resort treatment for multidrug-resistant Gram-negative infections including pneumonia. These may involve bacteria such as ''Pseudomonas aeruginosa'', ''Klebsiella ...

(a comparator antibiotic) for up to 14 days. Both treatment arms also received an additional antibiotic,

imipenem/cilastatin Imipenem/cilastatin, sold under the brand name Primaxin among others, is an antibiotic useful for the treatment of a number of bacterial infections. It is made from a combination of imipenem and cilastatin. Specifically it is used for pneumonia, ...

, as background therapy for potential hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia pathogens other than ''Acinetobacter baumannii-calcoaceticus'' complex. 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. 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.

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%.

Society and culture

Legal status

Sulbactam/durlobactam was approved for medical use in the United States in May 2023. The FDA granted the application for sulbactam/durlobactam

fast track Fast Track, Fast track, or Fasttrack may refer to: Processes and systems * Fast track (FDA), a U.S. Food and Drug Administration expedited review program * Fast track (trade), the authority of the U.S. President to broker trade agreements with lim ...

and

priority review Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...

designations.

References

External links

* Beta-lactamase inhibitors Combination antibiotics {{Pharma-stub