Pivya (pivmecillinam; Utility Therapeutics) tablets have received FDA approval for managing uncomplicated urinary tract infections (UTIs) associated with Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus in female adults.
Takeaways
- Pivya tablets have gained FDA approval for treating uncomplicated UTIs in adult females.
- Three controlled clinical trials evaluated Pivya's efficacy, comparing it with placebo, other antibacterial drugs, and ibuprofen, with composite response rates as the primary outcome measure.
- Pivya demonstrated significant efficacy, with composite response rates ranging from 62% to 72% across trials.
- Diarrhea and nausea emerged as common side effects associated with Pivya.
- The FDA cautions against Pivya use in patients with severe hypersensitivity to beta-lactam antibacterial drugs, primary or secondary carnitine deficiency, or porphyria.
Uncomplicated UTIs, defined as bacterial bladder infections in female adults with no structural abnormalities in their urinary tract, present at least once in approximately 50% of women. To evaluate the efficacy of Pivya in managing the condition among female patients aged 18 years and older, 3 controlled clinical trials were conducted.
In the trials, various dosing regimens of Pivya were compared to either placebo, another oral antibacterial drug, or the anti-inflammatory drug ibuprofen. The composite response rate was reported as the primary outcome of the trials, and included clinical cure and microbiological response, evaluated approximately 8 to 14 days after enrollment.
The first trial reported a 62% composite response rate for Pivya vs 10% for placebo. The second trial reported a rate of 72% for Pivya vs 76% for a comparator oral antibacterial drug. Finally, the third trial reported a rate of 66% for Pivya vs 22% for ibuprofen.
Common side effects for Pivya included diarrhea and nausea. The FDA warned against use of the tablets in patients with a history of severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs, primary or secondary carnitine deficiency, or porphyria.
“Uncomplicated UTIs are a very common condition impacting women 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 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,” Kim added.
Reference
FDA Approves New Treatment for Uncomplicated Urinary Tract Infections. US Food and Drug Administration. April 24, 2024. Accessed April 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections
