Pivya Approved to Treat Uncomplicated UTI in Female Patients

The Food and Drug Administration (FDA) has approved Pivya (pivmecillinam) for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

Pivmecillinam is a prodrug of mecillinam, a beta-lactam antibacterial drug. The approval was based on data from three phase 3 trials, which compared the efficacy of different dosing regimens of pivmecillinam to placebo, to another oral antibacterial drug (cephalexin), and to ibuprofen (ClinicalTrials.gov Identifier: NCT01849926).

The primary efficacy measure for all 3 trials was the composite response rate, which included clinical cure (defined as no persisting symptoms during and after therapy) and microbiological response (defined as a reduction in the number of bacteria to <10³ CFU/mL). The composite response rate was assessed approximately 8 to 14 days after patients were enrolled into the studies.

Findings from the placebo-controlled clinical trial showed 62% (n=85/137) of patients in the pivmecillinam arm achieved the composite response vs 10% (n=14/134) of those in the placebo arm (treatment difference, 52% [95% CI, 41-62]). 

In the cephalexin-controlled clinical trial, 72% (n=91/127) of patients in the pivmecillinam arm achieved the composite response vs 76% (n=100/132) of those in the cephalexin arm (treatment difference, -4% [95% CI, -16, 7]).

In the ibuprofen-controlled clinical trial, 66% (n=69/105) of patients in the pivmecillinam arm achieved the composite response vs 22% (n=26/119) of patients in the ibuprofen arm (treatment difference, 44% [95% CI, 31-57]).

Pivya is contraindicated in: patients with a known history of severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs; patients with primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, and other inborn errors of metabolism; and patients who are suffering from porphyria. The most common adverse reactions reported with Pivya were nausea and diarrhea.

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs.” 

Pivya is supplied as 185mg pivmecillinam tablets. The recommended dosage is one 185mg tablet orally three times a day for 3 to 7 days as clinically indicated.