- The FDA has approved the drug pivmecillinam for “uncomplicated” urinary tract infections
- It will be sold under the Pivya brand in the United States starting in 2025.
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For the first time in two decades, a new pill has been approved for urinary tract infections in hopes of combating antibiotic-resistant bugs.
The FDA has approved the drug pivmecillinam, sold under the brand name Pivya, for “uncomplicated” urinary tract infections, meaning the infection is contained within the bladder and has not spread to the kidneys.
It has been used as a first-line treatment in Europe for more than 40 years, but next year it will be available by prescription to millions of American women ages 18 and older.
Utility Therapeutics, the company developing the drug, is also seeking approval for an intravenous version administered in the hospital for more serious infections.
The FDA approved the drug pivmecillinam, sold as Pivya in the US, for “uncomplicated” urinary tract infections, meaning the infection is contained within the bladder and has not spread to the kidneys.
“Uncomplicated urinary tract infections are a very common condition affecting women and one of the most common reasons for antibiotic use,” said Dr. Peter Kim, director of the Division of Antiinfectives at the U.S. Center for Evaluation and Research. FDA Drugs.
“The FDA is committed to promoting the availability of new antibiotics when they are proven to be safe and effective.”
It is the first time in 20 years that the FDA has approved a new antibiotic for urinary tract infections, which affect 30 million Americans each year.
Antibiotic resistance is a growing problem, when pathogens adapt in a way that allows them to resist powerful drugs designed to kill them.
The problem is associated with almost five million deaths, according to the World Health Organization.
Most urinary tract infections occur when bacteria such as E. coli travel from the rectum, genital area, or vagina to the urethra and bladder.
As the bacteria multiply, patients may experience abdominal cramps, burning sensations, and blood in the urine.
While men can get urinary tract infections, the problem overwhelmingly affects women more often. More than half of women in the U.S. will experience a UTI at some point in their lives, compared to only 14 percent of men.
This is because women have shorter urethras than men, which means it is easier for bacteria to reach the urinary tract.
About a quarter of women suffer from recurrent UTIs, which are defined as at least two infections in six months, or three in a year.
Most UTIs are now resistant to at least one antibiotic. Ampicillin, once a common treatment, is now rarely used.
Studies have shown that more than 92 percent of the bacteria that cause a UTI are resistant to at least one common antibiotic, and about 80 percent are resistant to at least two.
If infections have reached the kidneys or pass into the bloodstream, this makes them more difficult to treat.
Pivmecillinam has been prescribed more than 30 million times in Europe, with most of its use occurring in the Nordic countries, and reports of complications have been rare.
The most common side effects of pivmecillinam in clinical trials were nausea and diarrhea, the FDA said.
said Dr. Shruti Gohil, a professor of infectious diseases at the University of California, Irvine School of Medicine. The New York Times pivmecillinam represented an “interesting new possibility for the treatment of lower urinary tract infections.”
“But I would also say that it will be important that we use the drug responsibly in this country so that we don’t create resistance to it.”