A New Oral Antibiotic Is Available to Treat UTIs

For the first time in 20 years, there’s a new FDA-approved oral antibiotic for the treatment of uncomplicated urinary tract infections (UTIs) in women. The drug, Pivya (pivmecillinam), adds a new tool for clinicians to treat common infections that are increasingly unresponsive to existing antibiotics.

Pivya is a synthetic version of penicillin that can treat UTIs caused by some of the most common UTI-causing bacteria. It has been used as a first-line treatment in Canada and parts of Europe for more than 40 years.

About half of all women get at least one UTI in their lifetime, and about a quarter of women experience recurrent UTIs.

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, said in a statement.

A UTI is considered “uncomplicated” when it occurs in people who have no known risk factors that would make them particularly susceptible to developing a UTI, said Sarah McAchran, MD, FACS, a urologist, urogynecologist, and associate professor at the University of Wisconsin.

“It’s going to be fantastic to have another option for patients,” McAchran said. “It should breed less antibiotic resistance than some of the other antibiotics that we use to treat recurrent urinary tract infections.”

A New Drug to Tackle Antibiotic Resistance

Pivya can neutralize three bacteria that cause UTIs: Escherichia coli, Proteus mirabilis, or Staphylococcus saprophyticus. E. coli is the most common cause of UTIs.

Many common antibiotics have become less effective at treating UTIs in recent years because the bacteria that cause the infections have grown more resistant to the treatment. Antibiotic resistance is a particularly big problem for UTIs because of how common they are.

More than one in five samples of urine containing E. coli were resistant to first- and second-line antibiotics, according to a 2022 World Health Organization report. In a 2019 study, 80% of urine samples were resistant to treatment by at least two common antibiotics.

The FDA advises against prescribing antibiotics if there is no evidence that a person’s symptoms are caused by a bacterial infection, as this could fail to treat the condition and potentially increase antibiotic resistance.

Pivya may not contribute as greatly to antibiotic resistance because it doesn’t reach high concentrations in the gut. The fewer bacteria are exposed to the medication, the less time they have to evolve to become resistant to it.

In Denmark and Norway, where pivmecillinam has been used for decades, there is only 4%-6% resistance to the drug.

“Any advancements that allow therapies to be specifically targeted to the urinary tract, without affecting other parts of the body, decrease the risk of adverse effects, decrease the risk of ‘collateral effects,’ and decrease the risk of developing antibiotic resistance,” McAchran said.

How Pivya Is Used

The FDA label instructs Pivya users to take one 185-milligram tablet by mouth three times a day for three to seven days, or per their health provider’s instructions. It can be taken with or without food.

The FDA said it’s important to take the full course of the drug, even if you feel better before finishing all the pills. If not, the infection could come back, or bacteria in your body could become resistant to the drug.

McAchran said Pivya could be used as a first-line treatment both for first-time and recurrent UTIs.  

McAchran said many people access UTI treatment through telehealth, which means they may not be able to provide samples for lab testing. However, she said most people can correctly judge whether they have a UTI based on symptoms alone. Pivya should be able to treat most standard cases without the person needing to get a test.

“Certainly for someone who’s coming back with a second infection or for a recurrent infection, that’s where we want to make sure that we’re getting culture data to figure out what bacteria is growing and what it’s sensitive to,” McAchran said.

Those include people who are born with an anomaly in their urinary tract, had prior surgery in the urinary tract, are pregnant, or don’t empty appropriately for another reason.

When treating complicated UTI cases, clinicians usually culture the patient’s urine and offer personalized treatment based on which bacteria are causing their infection.

Efficacy and Side Effects

Clinical trials for pivmecillinam date back to the 1970s. The FDA granted approval based on three clinical trials to see which dosing regimen worked best, whether that dose performed better than another oral antibacterial drug, and whether it performed better than ibuprofen.

More than 60% of the patients who received Pivya saw their symptoms resolve and no new symptoms between one and two weeks after taking the drug, compared to 10% of those who took a placebo. When compared to another oral antibiotic, 72% of those who took Pivya recovered compared to 76% on the comparator drug.

The most common side effects of Pivya include nausea and diarrhea, the FDA said.

The FDA said people with serious hypersensitivity to beta-lactam antibacterial drugs like penicillin should not take Pivya. The other contraindications include very rare metabolic disorders.