Uncomplicated Urinary Tract Infection Tablets Approved in the U.S.

For decades, antibiotics have been a mainstay of treatments for urinary tract infections (UTIs). Still, the growing threat of antibiotic resistance has limited clinicians' options to control infections effectively.

A 2022 World Health Organization surveillance report found that the most common cause of UTIs is resistance to first—and second-line antibiotics.

Research indicates that 40% of women in the United States will develop a UTI at some point in their lifetime.

If not managed effectively, UTIs can lead to more significant illness—additional rounds of treatment and prevalent hospitalization.

To address this substantive women's health issue, the U.S. Food and Drug Administration approved UTILITY therapeutics Ltd.'s Pivya™ (pivmecillinam) tablets for the treatment of female adults with uncomplicated UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis. and Staphylococcus saprophyticus. 

According to the Company, Pivya is the first FDA antibiotic approved for UTIs in decades and should be available in the U.S. in 2025.

This UTI tablet has been in use throughout Europe for years.

"Uncomplicated UTIs are a prevalent condition impacting women and one of the most frequent reasons for antibiotic use," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, in a press release on April 25, 2024.

Pivya's efficacy in treating adult females with uncomplicated UTIs was assessed in three controlled clinical trials comparing dosing regimens to placebo, another oral antibacterial drug, and ibuprofen.

The composite response rate was assessed approximately 8 to 14 days after patients were enrolled in the studies.

In the clinical trial comparing Pivya to placebo, 62% of the 137 subjects who received Pivya achieved the composite response compared to 10% of the 134 who received placebo.

In the clinical trial comparing Pivya to another oral antibacterial drug, 72% of the 127 subjects who received Pivya achieved composite response compared to 76% of the 132 who received the comparator drug.

In the clinical trial comparing Pivya to ibuprofen, 66% of the 105 subjects who received Pivya achieved composite response compared to 22% of the 119 who received ibuprofen. 

Pivya comes with specific warnings and precautions. The most common side effects of Pivya included nausea and diarrhea.

For men and women with recurrent UTIs, Immunotek S.L. Uromune™ (MV140) inactivated oral spray vaccine is approved for adults in various countries, but not the U.S. 

Uromune vaccine appointment requests can be scheduled using this PVax link.