India Pharma Outlook Team | Saturday, 27 April 2024
Utility Therapeutics Ltd has received FDA approval for Pivya (pivmecillinam) tablets to treat female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
"Uncomplicated urinary tract infections are a very common condition impacting women and one of the most frequent reasons for antibiotic use," said Peter Kim, director of the Division of Anti-Infectives in the US FDA's Center for Drug Evaluation and Research. "The US 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."
Females without structural problems in their urinary tract are at risk for uncomplicated urinary tract infections, which are bacterial infections of the bladder. About 50% of women will at some point in their lives get a urinary tract infection.
In three carefully monitored clinical trials, the effectiveness of Pivya in treating females with simple UTIs who were 18 years of age or older was evaluated by contrasting various Pivya dosage schedules with a placebo, with another oral antibacterial medication, and with ibuprofen (an anti-inflammatory treatment). The composite response rate, which included clinical cure (resolution of the uncomplicated UTI symptoms that patients had at trial entry and no new symptoms) and microbiological response (proof that the amount of bacteria cultured from patients' urine at trial entry was decreased) was the main metric used to assess the efficacy of the three trials.
Eight to fourteen days after patients were recruited in the studies, the composite response rate was evaluated. In the clinical trial where Pivya and placebo were compared, 62% of the 137 Pivya-treated participants and 10% of the 134 placebo-treated subjects attained the composite response.
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