There's a New Treatment for UTIs—Here's What You Need to Know Find out more about the new drug
For the first time in two decades, the FDA has approved a new antibiotic to treat uncomplicated UTIs in women
- The FDA recently approved Pivya (pivmecillinam) for the treatment of uncomplicated urinary tract infections (UTIs) in women over 18.
- Pivya is a narrow-spectrum antibiotic and is approved to treat infections caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
- Experts said the new drug provides a much-needed option for treating the painful infections.
For the first time in 20 years, the Food and Drug Administration has approved a new oral antibiotic to treat urinary tract infections.
The drug, Pivya (pivmecillinam), is approved to treat women over 18 with uncomplicated UTIs, which are contained in the bladder and haven’t spread to the kidneys. Compared to complicated UTIs, uncomplicated ones are less severe and more prevalent, affecting more than half of women during their lifetime.
“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, MD, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective.”
The FDA’s sign-off gives medical providers a much-needed additional treatment option for the painful infections, Kyle Graham, MD, a board-certified OB-GYN and medical director at Pediatrix Medical Group in San Jose, California, told Health.
“Having another antibiotic available to treat UTIs helps us treat UTIs that are resistant to commonly used antibiotics,” he said.
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What Is Pivya—and How Effective Is it?
Pivya is a synthetic version of penicillin that’s been used in Europe as a first-line treatment for uncomplicated UTIs for over 40 years.
The FDA approved pivmecillinam to treat infections caused by Proteus mirabilis, Staphylococcus saprophyticus, and Escherichia coli—the pathogen involved in about 75% of uncomplicated UTI cases.
“Pivya is a narrow-spectrum antibiotic, meaning it kills only a small number of bacterial species,” Seth A. Cohen, MD, a urologic surgeon and urogynecologist at California’s City of Hope Orange County Lennar Foundation Cancer Center, told Health.
Graham explained that it works “by building up the highest concentrations in the bladder and not in other organs,” which is why it’s not meant to treat complicated UTIs.
The first studies showing the drug’s effectiveness date back to the 1970s. Those studies found that pivmecillinam cured 85% of UTIs with just a three-day course of the drug.
In a statement, the FDA cited three clinical trials that tested how well various Pivya dosing regimens worked in UTI patients compared to placebo or other treatments.
One trial found that 62% of people taking Pivya had resolved and no new symptoms, compared to just 10% in a placebo group. Another trial showed that 72% of participants recovered after taking Pivya, compared to 76% who took a different oral antibiotic. The third study found 66% of people taking Pivya saw resolved symptoms, while only 22% of ibuprofen users recovered.
A Welcomed Option
Pivya’s approval comes amid mounting concerns over resistance of bacteria to current UTI treatments. One 2019 study found that more than 92% of UTI-causing bacteria are resistant to at least one common antibiotic, and almost 80% are resistant to at least two.
Cohen said having another go-to drug available is welcome news and that it also appears that Pivya will be in wide supply. This means that if there’s a shortage of other antibiotics, Pivya may be a drug that healthcare providers in the U.S. can reliably count on.
Graham reported that Utility Therapeutics, the company that acquired the right to pivmecillinam, said Pivya would be available in 2025.
Usage and Side Effects
The FDA recommends that people with uncomplicated UTIs take one 185 milligram (mg) tablet of Pivya three times daily for three to seven days.
For a UTI to be considered uncomplicated, a person also can’t be using a catheter, experiencing a fever, pregnant, immunocompromised, or have a structural abnormality of the urinary tract.
Other groups that shouldn’t take Pivya, per the FDA, include:
- People who are allergic to penicillin
- People with porphyria, a rare disease in which the body abnormally metabolizes the blood pigment hemoglobin
- People who are deficient in carnitine, a natural substance acquired chiefly through food that helps the body process fats and produce energy
The most common side effects of Pivya are nausea and diarrhea, though the FDA reports that they only occurred in less than 5% of clinical trial participants.
This story originally appeared on: Health News - Author:Sherri Gordon
