Pivya Now Available for Adult Female Patients With Uncomplicated UTI

Pivya (pivmecillinam tablets) is now available for the treatment of female patients aged 18 years and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. The penicillin class antibacterial was approved for use in the US in 2024 and has been available for decades in Europe.

The approval was based on results from three phase 3 trials. These studies compared different dosing regimens of pivmecillinam with placebo, cephalexin, and ibuprofen, respectively. The primary endpoint for all 3 trials was the composite response of clinical cure and microbiological response.

Findings from the placebo-controlled clinical trial showed 62% of patients in the pivmecillinam arm achieved the composite response vs 10% of those in the placebo arm (treatment difference, 52% [95% CI, 41-62]).

In the cephalexin-controlled clinical trial, 72% of patients in the pivmecillinam arm achieved the composite response vs 76% of those in the comparator arm (treatment difference, -4% [95% CI, -16, 7]).

In the ibuprofen-controlled clinical trial, 66% of patients in the pivmecillinam arm achieved the composite response vs 22% of patients in the ibuprofen arm (treatment difference, 44% [95% CI, 31-57]).

Pivya is supplied as a 185mg tablet and is available in a blister pack containing 9 tablets. The recommended dosage is 1 tablet orally 3 times daily for 3 to 7 days as clinically indicated. The drug may be taken with or without food. The most common adverse reactions reported with treatment were nausea and diarrhea.