Prescription-Event monitoring study on safety and efficacy of levonadifloxacin (oral and I.V.) in management of bacterial infections: Findings of real-world observational study

Abstract

Background: Levonadifloxacin is a novel broad-spectrum antibiotic belonging to the benzoquinolizine subclass of quinolones. It is available in intravenous as well as oral formulation for the treatment of infections caused by common Gram-positive bacterial pathogens including methicillin-resistant Staphylococcus aureus (MRSA). Patients and Methods: This study retrospectively assessed the real-world safety and efficacy of levonadifloxacin (oral and/or IV) in the treatment of 1229 patients across various clinical conditions. Study outcomes were clinical and microbiological success at the end of therapy. Results: The mean duration of levonadifloxacin therapy was 7.2 days, with a time to clinical improvement averaging at 4 days. Three hundred and three patients received oral therapy, 875 received IV, and 51 received a combination of IV followed by oral therapy. Patients were prescribed levonadifloxacin for skin and soft-tissue infections, diabetic foot infections, septicemia, catheter-related bloodstream infections, bone and joint infections, febrile neutropenia, and respiratory infections including COVID-19 pneumonia. High clinical success rates of 98.3%, 93.7%, and 96.1% with oral, IV, and IV followed by oral levonadifloxacin, respectively, were obtained. Only 11 mild adverse events were reported in 9 patients which included constipation, diarrhea, hyperglycemia, nausea, fatigue, and vomiting. Overall, 96.3% and 97.3% of investigators rated the efficacy and safety of levonadifloxacin as “good to excellent.” Conclusions: An excellent safety and efficacy profile of levonadifloxacin was observed in this study making it a suitable treatment option for management of various bacterial infections, including those caused by resistant Gram-positive pathogens such as MRSA and quinolone-resistant S. aureus .

Antibiotics in the clinical pipeline as of December 2022

“…Both the IV and oral formulations were approved in January 2020 by the Indian Central Drugs Standard Control Organization (CDSCO) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections and concurrent bacteremia [ 42 , 43 ]. Levonadifloxacin ( 1 ) has activity against G+ve bacteria including MRSA, as well as some G-ve bacteria [ 41 ], and a prescription-event monitoring study was recently published [ 44 ]. Racemic nadifloxacin was first approved in 1993 to topically treat acne and MRSA infections [ 45 ].…”

Meeting the Unmet Need in the Management of MDR Gram-Positive Infections with Oral Bactericidal Agent Levonadifloxacin

“…e clinical success rate for treating febrile neutropenia with levonadifloxacin medication (oral/ IV) was found to be 93.8% in the PIONEER research [72]. 9.4.…”

“…[68,73]. Levonadifloxacin demonstrated very good results in PIONEER study for BJI, with clinical success rates of 100% [72]. Additional research works employing BJI animal models as well as human trials are required to thoroughly examine levonadifloxacin therapy and its positioning in the treatment of these infections.…”

“…Levonadifloxacin has also proved to be an effective agent for prophylaxis of febrile neutropenia because of its good safety and efficacy profile. The clinical success rate for treating febrile neutropenia with levonadifloxacin medication (oral/IV) was found to be 93.8% in the PIONEER research [ 72 ].…”

“…Studies have shown excellent levonadifloxacin's resistance mechanisms such as the NorA efflux pump, DNA Gyrase/Topo IV mutations, and biofilm formation, which indicate that this drug can potentially be used to treat difficult-to-treat BJI [ 68 , 73 ]. Levonadifloxacin demonstrated very good results in PIONEER study for BJI, with clinical success rates of 100% [ 72 ]. Additional research works employing BJI animal models as well as human trials are required to thoroughly examine levonadifloxacin therapy and its positioning in the treatment of these infections.…”