The U.S. Food and Drug Administration has approved the first new antibiotic in two decades to treat urinary tract infections (UTIs).
The drug, pivmecillinam (Pivya), is approved to treat women 18 and older who have what’s known as uncomplicated UTIs — infections that haven’t spread beyond the bladder to the kidneys — the FDA said in a statement. It may offer a treatment option to women who have infections caused by bacteria such as Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus that have become increasingly difficult to treat with other antibiotics.
“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” Peter Kim, MD, director of the division of anti-infectives in the FDA’s Center for Drug Evaluation and Research, said in the statement. Half of all women will experience at least one UTI at some point in their life, according to the FDA.
“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective,” Dr. Kim said. “Pivya will provide an additional treatment option for uncomplicated UTIs.”
UTIs Increasingly Involve Drug-Resistant Bacteria
Many strains of E. coli, a common cause of UTIs, don’t respond to treatment with one or more antibiotics, according to the Centers for Disease Control and Prevention (CDC).
UTIs, also called bladder infections, are most often caused when bacteria that are typically found in the digestive tract migrate to the urinary tract during sex or while wiping after a bowel movement. Symptoms can be painful and include frequent urination, pain during urination, and feeling the need to urinate even with an empty bladder.
The FDA reviewed results from three late-stage clinical trials of pivmecillinam to see how often it both cured UTIs — meaning women had no more symptoms — and significantly reduced bacteria levels present in urine.
One trial compared pivmecillinam to a placebo, or dummy pill, and found the antibiotic met these two goals in 62 percent of cases, compared with 10 percent with the placebo, the FDA said. Another trial found pivmecillinam achieved both goals in 66 percent of cases, compared with 22 percent for people who were given ibuprofen instead, the FDA reported. A third trial found that pivmecillinam achieved these two goals in 72 percent of cases, compared with 76 percent for a different oral antibiotic, the FDA said.
What Are the Side Effects of Pivmecillinam (Pivya)?
The most common side effects of pivmecillinam included nausea and diarrhea, according to the FDA.
What pivmecillinam offers patients is a new treatment option when they can’t treat UTIs with other antibiotics because they have an infection caused by a bacteria resistant to older drugs or because they have an allergy to one or more commonly prescribed antibiotics, says Thomas Hooton, MD, an infectious disease specialist and voluntary retired professor at the University of Miami Miller School of Medicine.
“Pivmecillinam offers another option,” Hooton adds. “It may have better activity against some of the resistant pathogens we see in UTI.”
Lisa Rapaport is a journalist with more than 20 years of experience on the health beat as a writer and editor. She holds a master’s degree from the UC Berkeley Graduate School of Journalism and spent a year as a Knight-Wallace journalism fellow at the University of Michigan. Her work has appeared in dozens of local and national media outlets, including Reuters, Bloomberg, WNYC, The Washington Post,Los Angeles Times, Scientific American, San Jose Mercury News, Oakland Tribune, Huffington Post, Yahoo! News, The Sacramento Bee, and The Buffalo News.
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