There’s a New Antibiotic for UTIs in Town

The U.S. Food and Drug Association (FDA) has approved Pivya, the latest treatment for uncomplicated urinary tract infections, which are increasingly resistant to antibiotics.

About half of women experience at least one urinary tract infection (UTI) in their lifetime, increasing their risk of developing it in the future. The condition is normally treated with a short course of antibiotics, and the symptoms can be relieved by taking painkillers and drinking plenty of fluids.

Pivya (pivmecillinam) tablets are intended for use in women aged 18 and older with uncomplicated UTIs caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus bacteria. An uncomplicated UTI refers to an infection that only affects the bladder and hasn’t reached the kidneys.

Pivya’s efficacy was evaluated in three controlled clinical trials comparing its different dosing regimens to placebo, another oral antibacterial drug, and ibuprofen.

In the clinical trial comparing pivmecillinam to placebo, 62% of the participants who received Pivya had their symptoms resolved in eight to 14 days, compared to 10% in the placebo group.

Pivya was not found to be superior to another oral antibacterial drug: 72% of the participants on pivmecillinam experienced the resolution of symptoms, compared to 76% of those who received the comparator drug.

Sixty-six percent of the participants who received Pivya had their symptoms resolved, compared to 22% in the ibuprofen group.

“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs,” 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 statement.

In Europe, pivmecillinam has been used as a first-line treatment for uncomplicated UTIs for more than 40 years.

Pivya is the first FDA-approved antibiotic for uncomplicated UTIs in the last two decades. The approval comes at a critical time when antibiotic resistance is increasing globally.

According to a 2022 surveillance report from the World Health Organization, over 20% of isolates from E. coli, the bacterium responsible for most UTI cases, were resistant to first- and second-line antibiotics.

The most common side effects of Pivya included nausea and diarrhea.

Pivya should not be taken by individuals who are sensitive to other beta-lactam antibacterial drugs, such as carbenicillin, penicillin G, ticarcillin, and ampicillin, among others.

What are the causes of UTIs?

UTIs are more common in females because their urethras are shorter and closer to the rectum, making it easier for bacteria to enter the urinary tract. Other risk factors include the following:

  • Having had a UTI in the past.
  • Being sexually active.
  • Experiencing changes in the bacteria that live inside the vagina, or vaginal flora, such as caused by menopause or the use of spermicides.
  • Being pregnant.
  • Being a young child or an older adult.
  • Having structural problems in the urinary tract, such as an enlarged prostate.
  • Maintaining poor hygiene, for example, in children who are potty-training.

The symptoms of a UTI in the bladder can include pain or burning while urinating, frequent urination, and feeling the need to urinate despite having an empty bladder. For some people, the infection causes bloody urine and pressure or cramping in the groin or lower abdomen.

When the infection reaches the kidneys, it may cause fever, chills, lower back pain, or pain in the side of the back, as well as nausea and vomiting.

UTI treatments for women

If you think you have a UTI, your healthcare provider will prescribe you an antibiotic for treatment. Once you receive a prescription, make sure you finish your entire course of antibiotics to prevent the infection from returning.

Common antibiotics include:

  • Nitrofurantoin
  • Sulfonamides
  • Amoxicillin
  • Cephalosporins
  • Doxycycline
  • Fosfomycin
  • Quinolones

Most people will start feeling better after a few days. If your UTI is recurring, visit your healthcare provider again for a low-dose, longer antibiotic.

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