Comprehensive introduction and marketing status of sulbactam sodium and dulobactam sodium/sulbactam-durobactam (Xacduro)

Sulbactam Sodium and Dulobactam Sodium (Xacduro), as an innovative antibiotic combination drug, is designed to treat severe infections caused by susceptible strains of Acinetobacter baumannii-calcium acetate complex. Such infections, especially hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), often become resistant to conventional antibiotics, posing great challenges to patient treatment. The launch of Xacduro provides clinicians and patients with a new and effective treatment option.

Xacduro consists of two ingredients, sulbactam sodium and dulobactam sodium. These two ingredients work synergistically to significantly enhance the bactericidal effect of antibiotics on drug-resistant Acinetobacter baumannii by inhibiting the activity of beta-lactamase. This unique mechanism allows Xacduro to demonstrate significant efficacy and safety in the treatment of such serious infections.

In terms of going public,Xacduro’s journey has been rapid and high-profile. In May 2023, Xacduro received approval from the U.S. Food and Drug Administration (FDA) for the treatment of HABP and VABP caused by susceptible isolates of the Acinetobacter baumannii-calcacetic acid complex in people 18 years of age and older. This approval is based on a body of scientific evidence, including results from the landmark Phase 3 clinical ATTACK study, which demonstrated that Xacduro is statistically non-inferior to conventional therapies in the safety and efficacy of polymyxin E in the treatment of patients with Acinetobacter infection.

Subsequently, in May 2024, China's National Medical Products Administration (NMPA) also approved Xacduro for marketing in China through the priority review and approval process for the treatment of the same indications. The rapid approval of this drug reflects the great importance that domestic and foreign regulatory agencies attach to the research and development of innovative drugs and their urgent desire to meet urgent clinical drug needs.

In general, the launch of sulbactam sodium and dulobactam sodium (Xacduro) provides a new solution for the treatment of drug-resistant Acinetobacter baumannii infections and brings new hope to patients.

Reference: https://www.drugs.com/xacduro.html