FDA approves new medication for uncomplicated urinary tract infections in women

April 24 (UPI) -- The newly approved oral medication Pivya provides women with another option for treating uncomplicated urinary tract infections, the U.S. Food and Drug Administration announced Wednesday.

"Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use," said Dr. Peter Kim, director of the anti-infectives unit at the FDA's Center for Drug Evaluation and Research.

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

Bacterial infections of the bladder in women with no urinary tract abnormalities cause uncomplicated UTIs, according to the FDA.

FDA officials said about half of all women experience UTIs at least once during their lifetimes.

Pivya tablets help treat UTIs caused by Escherichiacoli, Proteus mirabilis and Staphylococcus saprophyticus, the FDA said.

The federal agency said three clinical trials comparing varying dosages of Pivya and a placebo, other antibacterial drugs and ibuprofen showed Pivya was significantly more effective at treating women with UTIs.

Common side effects include diarrhea and nausea.

The FDA says patients with a history of severe hypersensitivity to Pivya, which is pivmecillinam, and other beta-lactam anti-bacterial drugs shouldn't use Pivya.

Women diagnosed with porphyria or who have primary or secondary carnitine deficiency due to genetic disorders of mitochondrial fatty acid oxidation and carnitine metabolism also shouldn't use the medication.