lterum Therapeutics U.S. Ltd.: sulopenem etzadroxil

There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in 21CFR §314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling (21 CFR §314.125(b)(5)).

The clinical data submitted from Study 301 do not provide substantial evidence of effectiveness of sulopenem etzadroxil and probenecid tablets for the proposed indication of treatment of adult women with uncomplicated urinary tract infections (uUT1) caused by designated susceptible microorganisms proven or strongly suspected to be nonsusceptible to a quinolone.

2. The other trials conducted with sulopenem failed to meet their primary endpoint, and therefore, could not provide evidence of effectiveness.

To address these deficiencies, we recommend you conduct at least one additional adequate and well-controlled study in uUTI and consider using a different active comparator drug in the study(ies) that is more reflective of currently recommended treatment for uUTI.

Prescribing Information" to read "Recommended Dosage: See prescribing information."