FDA Approves Antibiotic for Uncomplicated UTIs
Pivmecillinam (Pivya) was given the nod from the federal agency, and is indicated for female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
According to Utility Therapeutics’ website, pivmecillinam (oral) is an aminopenicillin, which is a specific class of beta-lactam antibiotics with a distinct mechanism of action Pivmecillinam is the prodrug of mecillinam and is rapidly converted into mecillinam in vivo.
Image Credit: FDA
Today, the FDA approved an antibiotic, Pivmecillinam (Pivya), to treat women for uncomplicated UTIs.
“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.1
The oral antimicrobial, was developed by UK-based biotechnology company Utility Therapeutics, and was approved for the indication of UTIs caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.1
Study Results
Today’s approval is based from data of its phase 3 clinical studies. Specifically, pivmecillinam’s efficacy in treating females 18 years of age or older with uncomplicated UTIs was assessed in 3 controlled clinical trials comparing different Pivmecillinam dosing regimens to placebo, to another oral antibacterial drug and to ibuprofen.1
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).1
The composite response rate was assessed approximately 8 to 14 days after patients were enrolled into the studies. In the clinical trial comparing pivmecillinam to placebo, 62% of the 137 subjects who received pivmecillinam achieved the composite response compared to 10% of the 134 who received placebo. In the clinical trial comparing Pivya to another oral antibacterial drug, 72% of the 127 subjects who received Pivya achieved composite response compared to 76% of the 132 who received the comparator drug.1
In the clinical trial comparing pivmecillinam to ibuprofen, 66% of the 105 subjects who received pivmecillinam achieved composite response compared to 22% of the 119 who received ibuprofen.1
Safety Profile
According to the investigators, the most common side effects of pivmecillinam included nausea and diarrhea. For patients who have a known history of severe hypersensitivity to pivmecillinam or other beta-lactam antibacterial drugs, they should not take this therapy. 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.1
The Agent
According to Utility Therapeutics’ website, pivmecillinam (oral) is an aminopenicillin, which is a specific class of beta-lactam antibiotics with a distinct mechanism of action Pivmecillinam is the prodrug of mecillinam and is rapidly converted into mecillinam in vivo. Due to its unique MOA, PIVYA (pivmecillinam, oral) may address the resistance issues facing other treatments in the United States.2
Clinically, the reason for the low resistance, as recently uncovered in peer-reviewed research, is the collateral sensitivity of pivmecillinam (oral), which is an evolutionary trade-off between pivmecillinam (oral) resistance and resistance towards other beta-lactam antibiotics.18 As a result, PIVYA (pivmecillinam, oral) can provide further benefits to the fight against rising levels of antibiotic resistance.2
The approval of this therapy will offer another therapy for this condition that affects millions of women. “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.1
References
1.FDA Approves New Treatment for Uncomplicated Urinary Tract Infections. FDA news statement. April 24, 2024. Accessed April 24, 2024
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections
2. Existing first-line treatments have declining utility in combating UTI, highlighting the need for innovative alternatives to better serve patients. to Utility Therapeutics. Accessed April 24, 2024.
https://utilitytherapeutics.com/our-focus/#product-pipeline
