— Oral antibiotic has capacity for unsuitable usage, firm states
by Katherine Kahn, Personnel Writer, MedPage Today
September 6, 2024
Ahead of an Antimicrobial Drugs Advisory Committee conference on Monday, FDA customers voiced continuous issues about the advantages versus threats of an unique oral antibiotic for the treatment of straightforward urinary system infections (uUTIs), including its capacity for improper usage.
The drug in concern– sulopenem etzadroxil/probenecid (sulopenem)– is a penem antibiotic with in vitro activity versus gram-positive, gram-negative, and anaerobic organisms consisting of Enterobacterales types that encode extended-spectrum β-lactamases (ESBLs) and AmpC-type β-lactamases.
Based upon combined information from stage III trial results, the FDA turned down the antibiotic in 2021 and suggested that Iterum Therapeutics perform an extra trial.
After finishing another stage III trial, Iterum resubmitted a brand-new drug application (NDA) in April of this year. Iterum is looking for approval for sulopenem etzadroxil/probenecid as treatment for uUTI in adult females triggered by prone organisms.
New prescription antibiotics are required for the treatment of uUTIs. Presently, oral first-line treatment of uUTIs consist of nitrofurantoin, trimethoprim-sulfamethoxazole, fosfomycin, and pivmecillinam (Pivya). Alternate drugs consist of amoxicillin or oral cephalosporins. Drug-resistant uUTI might need treatment with IV prescription antibiotics, the FDA pointed out.
“While there are several FDA-approved oral anti-bacterial drugs for the treatment of uUTI, treatment choices can be restricted by unfavorable responses and increasing antimicrobial resistance (AMR) to first-line anti-bacterial drugs, consisting of through production of extended-spectrum β-lactamases,” the company composed.
The stage III trial from the previous NDA application (Trial 301, SURE-1) revealed sulopenem etzadroxil/probenecid transcended to ciprofl