FDA Approves New Antibiotic For Urinary Tract Infections

A decades-old European antibiotic, pivmecillinam may treat UTIs that don’t respond to conventional antibiotics.

Urinary tract infections now have a new drug from the FDA after 20 years.
The FDA claimed pivmecillinam (Pivya) can treat uncomplicated UTIs in women 18 and older. It may help women with Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus infections that other antibiotics are failing to treat.

According to Peter Kim, MD, head of the FDA’s Center for Drug Evaluation and Research’s division of anti-infectives, uncomplicated UTIs are a common illness in women and a leading cause of antibiotic use. The FDA estimates that half of women will get a UTI.
Dr. Kim said the FDA promotes safe and effective new antibiotics. “Pivya will augment uncomplicated UTI treatment.”

UTIs Include More Drug-Resistant Bacteria

According to the CDC, many strains of E. coli, a major UTI cause, don’t react to antibiotics.
UTIs, commonly known as bladder infections, are usually caused by digestive system bacteria migrating to the urinary tract during intercourse or after a bowel movement. Urinating frequently, feeling the need to urinate even with an empty bladder, and pain are uncomfortable symptoms.

The FDA examined three late-stage clinical trials of pivmecillinam to see how often it healed UTIs and dramatically reduced urine bacteria.

The FDA reported that pivmecillinam met these two goals in 62% of trials compared to 10% of placebos. Pivmecillinam met both goals in 66% of another trial, compared to 22% for ibuprofen, the FDA reported. In a third trial, pivmecillinam met these two goals in 72% of cases, compared to 76% for another oral antibiotic, the FDA reported.

What Are Pivmecillinam (Pivya) Side Effects?

The FDA reported nausea and diarrhea as pivmecillinam’s main adverse effects.

Thomas Hooton, MD, an infectious disease specialist and voluntary retired professor at the University of Miami Miller School of Medicine, says pivmecillinam gives patients a new treatment option for UTIs caused by bacteria resistant to older antibiotics or allergies to one or more commonly prescribed antibiotics.

“Pivmecillinam offers another option,” Hooton says. “It may work better against some UTI-resistant pathogens.”