By IDSE News Staff
The FDA approved pivmecillinam (Pivya, Utility Therapeutics) to treat adult women with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
Uncomplicated UTIs are bacterial infections of the bladder in women with no structural abnormalities of their urinary tract. Approximately one-half of all women experience at least one UTI in their lifetime.
Pivmecillinam’s efficacy in treating women 18 years of age and older with uncomplicated UTIs was assessed in three controlled clinical trials comparing different pivmecillinam dosing regimens with placebo, another oral antibacterial drug and ibuprofen. 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 were reduced).
The composite response rate was assessed approximately eight to 14 days after patients were enrolled into the studies. In the clinical trial comparing pivmecillinam with placebo, 62% of the 137 patients who received pivmecillinam achieved the composite response compared with 10% of the 134 who received placebo. In the clinical trial comparing pivmecillinam with another oral antibacterial drug, 72% of the 127 patients who received pivmecillinam achieved the composite response compared with 76% of the 132 who received the comparator drug. In the clinical trial comparing pivmecillinam with ibuprofen, 66% of the 105 patients who received pivmecillinam achieved the composite response compared with 22% of the 119 who received ibuprofen.
“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, MD, MS, the director of the Division of Anti-Infectives in 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, and Pivya will provide an additional treatment option for uncomplicated UTIs.”
The most common side effects of pivmecillinam included nausea and diarrhea. Patients should not use pivmecillinam if they have a known history of severe hypersensitivity to pivmecillinam or other beta-lactam antibacterial drugs. Patients should also not use pivmecillinam if they have primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, or if they are suffering from porphyria.
Pivmecillinam comes with certain warnings and precautions such as hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, Clostridioides difficile–associated diarrhea and interference with a newborn screening test for isovaleric acidemia, a rare metabolic disorder.
Pivmecillinam was granted Priority Review and Qualified Infectious Disease Product designations for this indication.
