The US Food and Drug Administration has approved Pivya (pivmecillinam) tablets for to treat uncomplicated urinary tract infections (UTIs), caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
“Uncomplicated UTIs are a very common condition and one of the most frequent reasons for antibiotic use,” said Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA’s Centres for Drug Evaluation and Research. “Pivya will provide an additional treatment option for uncomplicated UTIs.”
Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract: at least 50% of all women experience at least one UTI in their lifetime.
Pivya’s efficacy in treating females 18 or older with the condition was assessed in three controlled clinical trials comparing different Pivya dosing regimens to placebo, to another oral antibacterial drug, and to ibuprofen (an anti-inflammatory drug).
The primary measure of efficacy for the three trials was the composite response rate, which included clinical cure (resolution of the symptoms of the uncomplicated UTI that were present in patients at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from patients’ urine at trial entry was reduced).
The composite response rate was assessed eight to 14 days after patients were enrolled.
In the clinical trial comparing Pivya to placebo, 62% of the 137 subjects who received Pivya achieved the composite response compared with 10% of the 134 given placebo. In the clinical trial comparing Pivya with another oral antibacterial drug, 72% of the 127 subjects who received Pivya achieved composite response compared with 76% of the 132 who received the comparator drug.
In the clinical trial comparing Pivya to ibuprofen, 66% of the 105 subjects who received Pivya achieved composite response compared with 22% of the 119 who received ibuprofen.
The most common side effects included nausea and diarrhoea.
Pivya comes with certain warnings and precautions such as hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, Clostridioides difficile-associated diarrhoea and interference with a newborn screening test for isovaleric acidemia, a rare metabolic disorder.
The FDA granted the approval of Pivya to UTILITY Therapeutics.
FDA article – FDA Approves New Treatment for Uncomplicated Urinary Tract Infections (Open access)
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