FDA Reviewers Voice Concerns Over Novel UTI Treatment - MedPage Today
FDA reviewers express concerns over the benefits vs. risks of sulopenem etzadroxil/probenecid, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs), ahead of an advisory committee meeting. The drug, with activity against gram-positive, gram-negative, and anaerobic organisms, was rejected in 2021 but resubmitted by Iterum Therapeutics in April after another phase III trial. The new trial data showed non-inferiority to amoxicillin/clavulanate but had a small sample size of resistant organisms, raising efficacy questions. The FDA warns of potential inappropriate use and antimicrobial resistance (AMR) risks, emphasizing the need for careful stewardship and guideline considerations.
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FDA advisory committee raises concerns over antibiotic resistance and inappropriate use of sulopenem for uUTIs in adult women, emphasizing the need for appropriate use guidelines and potential modifications to drug labeling to mitigate risks.
FDA reviewers express concerns over the benefits vs. risks of sulopenem etzadroxil/probenecid, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs), ahead of an advisory committee meeting. The drug, with activity against gram-positive, gram-negative, and anaerobic organisms, was rejected in 2021 but resubmitted by Iterum Therapeutics in April after another phase III trial. The new trial data showed non-inferiority to amoxicillin/clavulanate but had a small sample size of resistant organisms, raising efficacy questions. The FDA warns of potential inappropriate use and antimicrobial resistance (AMR) risks, emphasizing the need for careful stewardship and guideline considerations.