FDA Approves New Option for Uncomplicated UTIs in Women

The FDA approved pivmecillinam (Pivya) for the treatment of uncomplicated urinary tract infections (UTIs) in women caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus, the agency announced on Wednesday.

Pivmecillinam is an oral prodrug that is hydrolyzed to the active drug mecillinam, a beta-lactam antibiotic. According to pivmecillinam's manufacturer, UTILITY Therapeutics, both pivmecillinam and mecillinam have been used for more than 40 years outside the U.S. to successfully treat UTIs.

About half of all women experience at least one UTI in their lifetime.

"Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use," said Peter Kim, MD, of 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."

Approval of pivmecillinam was granted based on results of three clinical trials comparing the antibiotic to placebo, another oral antibiotic, or ibuprofen, the FDA said. The primary measure of efficacy in the three trials was a composite of clinical response, including resolution of UTI symptoms and no new symptom development, as well as microbiological response. Responses were assessed approximately 8 to 14 days after treatment with pivmecillinam.

Of the participants treated with pivmecillinam in the first trial, 62% achieved the composite response versus 10% of those who received a placebo. In the second trial, 72% of participants treated with pivmecillinam achieved the composite response compared with 76% of those who received a comparator antibacterial drug. And in the comparison of pivmecillinam with ibuprofen, 66% of participants who received pivmecillinam achieved the composite response compared with 22% of those who received ibuprofen.

The most common side effects with pivmecillinam included nausea and diarrhea. Pivmecillinam is contraindicated in individuals with a history of hypersensitivity to the drug or to other beta-lactam antibacterial drugs. In addition, pivmecillinam should not be prescribed to patients with porphyria or abnormalities in carnitine metabolism. The drug may also interfere with a newborn screening test for isovaleric acidemia, a rare metabolic disorder.

Previously, the FDA had granted pivmecillinam priority review status and qualified infectious disease product (QIDP) designation for the treatment of uncomplicated UTIs. QIDP provides expedited regulatory review and an additional 5 years of market exclusivity.

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