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The Food and Drug Administration approved Pivya to treat uncomplicated urinary tract infections in female adults. Maskot/Getty Images
  • The Food and Drug Administration (FDA) recently approved a new antibiotic to treat urinary tract infections (UTIs).
  • Doctors can now prescribe the drug, called Pivya (pivmecillinam), to female adults with uncomplicated UTIs.
  • Clinical trials show that Pivya is effective and side effects are limited.
  • As antibiotic resistance continues to increase, Pivya’s addition to available treatments is welcome.

Urinary tract infections (UTIs) are one of the most common reasons for visits to general practitioners. During their lifetimes, almost 1 in 2 females will experience a UTI, accounting for around 25% of all infections in females.

Treatment for a UTI may vary and often require antibiotics. Now, for the first time in 20 years in the United States, the FDA has approved a new oral antibiotic to treat uncomplicated UTIs. The drug, pivmecillinam, marketed as Pivya, is a synthetic version of penicillin.

Experts describe UTIs as “uncomplicated” when the urinary tract is otherwise healthy, and there are no ongoing chronic conditions, immune issues, recent urologic surgery, or pregnancy.

Treating UTIs with Pivya may be new in the U.S., but doctors in Canada and some European countries have been prescribing the drug for UTIs for the past 40 years. In fact, the first studies demonstrating Pivya’s effectiveness against uncomplicated UTIs were published in the 1970s.

Pivya is a narrow-spectrum antibiotic, meaning it kills only a small number of bacterial species. For this reason, Pivya is only approved for use in UTIs caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

The drug is owned by Utility Therapeutics, a company that focuses on treatments for UTIs.

The FDA’s April 24 approval of Pivya was based on the results of three clinical trials:

Pivya vs placebo

This study involved 271 participants. Of those who received Pivya, 62% achieved the composite response compared with 10% in the placebo group.

Pivya vs another antibacterial

For this study, scientists recruited 259 people. In total, 72% of those taking Pivya achieved a composite response, compared with 76% of those taking the other antimicrobial.

Pivya vs ibuprofen

In this study, involving 224 people, 66% of those taking Pivya achieved composite response compared with 22% of those taking ibuprofen.

The most important measure in these studies was the “composite response rate,” which combines two important outcomes:

  • Clinical cure: Symptoms of the uncomplicated UTI are gone and no new symptoms appear.
  • Microbiological response: Levels of bacteria in the urine are reduced.

The composite response rate means symptoms have subsided and the bacteria are gone.

Taken together, these studies demonstrate that Pivya worked better than placebo and ibuprofen and similarly to other available antibiotics. Side effects were also relatively minor. Most commonly, they included nausea and diarrhea.

Healthline asked Niels Frimodt-Møller, a professor in the Department of Clinical Microbiology at Rigshospitalet in Denmark and expert on UTIs, about the possible side effects of the new FDA-approved drug.

“All drugs have adverse effects, but this has relatively few. However, it does produce the same allergic reactions as other penicillins,” he said.

The FDA explains that certain people should avoid using Pivya, including those with “carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism.” Also, people living with porphyria should avoid the drug.

Healthline spoke with Bjørn Åsheim Hansen, MD from Vestfold Hospital Trust in Denmark, who has published papers on pivmecillinam.

“Of course, there are side-effects like nausea and rash as with every other drug. But Pivya is well tolerated,” Hansen said.

As the FDA mentioned, Hansen noted “there have been some concerns” about carnitine deficiency, which may cause serious symptoms. However, Hansen believes this has “insignificant clinical consequences,” and is currently writing a paper on the topic.

The prevalence of UTIs is on the rise, especially in higher-income countries, like the U.S.

UTIs are an unpleasant and painful experience for younger people. In older adults, who are more susceptible to them, UTIs can be even more serious, leading to hospitalization. In some cases, UTIs in older adults can be fatal.

While antibiotic treatment for UTIs is generally effective, a growing number of bacteria have developed ways to protect themselves against antibiotics, making them less effective. This is known as antibiotic resistance, and it is a serious and growing public health concern.

A global surveillance report from the World Health Organization, (WHO) found that around 20% of E. coli in urine samples — the most common cause of UTIs — were resistant to first- and second-line antibiotics. That’s around 1 in 5 UTI cases, according to the report.

Thomas Lodise, PharmD, PhD, a professor at Albany College of Pharmacy and Health Sciences and a clinical pharmacist at the Stratton VA Medical Center in Albany, New York, told Healthline that resistance to “two of the most widely used oral antibiotics for uncomplicated UTIs has been reported to exceed 20% in most regions of the U.S.”

This is why discovering new drugs or, as in this case, revisiting overlooked antibiotics, is an important area of research.

Having a new antibiotic to treat UTIs is a positive step forward, but it does not completely remove the issue of antibiotic resistance, a growing problem worldwide.

Møller explained that, while Pivya is a “great antibiotic for uncomplicated UTIs, if it’s used too broadly, it will generate resistance as do all other antibiotics.”

However, Hansen noted they “have used the drug for decades in Scandinavia and still resistance is not a problem.” Antibiotic resistance related to Pivya is still at low levels — around 5%.

According to some experts, this may be because Pivya does not interfere with bacteria living in the gut.

Hansen cited growing evidence that Pivya might also be effective against antibiotic-resistant E.coli, which could have future implications for how this drug is prescribed.

The FDA has approved the first new antibiotic to treat uncomplicated UTIs in two decades. The move will help health professionals navigate the growing issue of antibiotic resistance and bring relief to many people who experience this condition.