FDA approves pivmecillinam tablets to treat urinary tract infections for women

Key takeaways:

• Pivmecillinam was approved for uncomplicated urinary tract infections for women.
• Pivmecillinam led to higher symptom resolution and microbiological response vs. placebo, another antibacterial drug or ibuprofen.

The FDA approved pivmecillinam tablets to treat uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus for women, according to an agency press release.

Pivmecillinam (Pivya, Utility Therapeutics) is an oral prodrug of injectable mecillinam.

The FDA approval was based on results of three controlled clinical trials that compared different doses of pivmecillinam tablets with placebo, another oral antibacterial drug and ibuprofen. The primary outcome for all trials was the composite response rate, including resolution of uncomplicated urinary tract infection symptoms present at trial entry and a reduction in bacteria cultured from patients’ urine at 8 to 14 days after enrollment.

In the trials comparing pivmecillinam with placebo and with ibuprofen, more women in the pivmecillinam group achieved the composite response (62% and 66%, respectively) compared with women in the placebo or ibuprofen groups (10% and 22%, respectively). In the trial comparing pivmecillinam with another oral antibacterial drug, 72% of women in the pivmecillinam group achieved the composite response compared with 76% in the comparator drug group, according to the release.

The most common adverse events of pivmecillinam were nausea and diarrhea, according to the release.

“Uncomplicated urinary tract infections are a very common condition impacting women and one of the most frequent reasons for antibiotic usePeter Kim, MD, MS, director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, said in the release. “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 urinary tract infections.”

Pivmecillinam was granted priority review and qualified infectious disease product designations for the treatment of uncomplicated urinary tract infections in women.