United States: Patients with recurrent urinary tract infections (UTIs) know it too that UTIs can come back even through use of antibiotics.
This news makes everyone happy, as the US Food and Drug Administration approved Pivya (pivmecillinam) yesterday for the purpose of fighting UTIs.
“UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Dr Peter Kim, who heads the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, in a conference release issued by the agency.
“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,” he added.
Pivmecillinam is well-established in most European countries, where it is invariably the first-choice antibiotic for women with simple UTIs.
Statistically, each woman will encounter at least one urinary tract infection (UTI) during her lifetime, according to the FDA. Uncomplicated UTIs have been detected in the bladders of female patients with no urinary tract abnormalities in their structural integrity.
Pivnet approximation was based on three clinical trials which involved women aged 18 years or older with uncomplicated UTIs. The discoverer of the new drug compared its effectiveness within an 8 to 14 day of use with that of ibuprofen and placebo in a single-blind trial.
Researchers looked at a combination of results: If bacterial counts in the urine of women decreased, and if UTI symptoms resolved, respectively, or not.
The tests found that Pivya got not only those results but also about the same as the drug from the other drugs (62% success against placebo and 72% and 76% regarding the other drug). Pivya’s performance outshone that of ibuprofen as it eliminated pain 66% of the time compared to 22%, as reported by the FDA.
As the New York Times reported, the FDA approval marks a major change since it’s been twenty years since a new antimicrobial agent for UTIs was approved.
Researchers looked at a combination of results: Either the insignificance of bacteria in women’s urine or the successful treatment venues of UTI will be explored.
Researchers evaluated how well Pivya worked against gonorrhea and found that it had the same success rate as placebo 62% of the time and was about as effective as the other antibacterial medicine(72% and 76% if the latter antibacterial medicine was taken, respectively). Pivya was almost twice as effective as ibuprofen, hence the figure of 66% as opposed to 22% was stated by the FDA.
It is narrated in the New York Times that the current event is the first new antibiotic to be given UTI approval by the FDA in the past two decades.
The prevalence of antibiotic-resistant organisms associated with UTIs and other kinds of infections is a matter of great concern for infectious disease specialists since urinary tract infections constitute approximately one-third of antimicrobial use in the United States.
“This is an exciting new possibility for treatment of lower urinary tract infections,” Dr. Shruti Gohil, a professor of infectious diseases at the University of California, Irvine School of Medicine, told the Times. “But I would also say that it is going to be important that we use the drug responsibly in this country so that we don’t breed resistance against it.”
Vomiting and diarrhea were the most occurring adverse effects of Privya, a drug manufactured by UTILITY Therapeutics Ltd.
The company spokesperson to the NYT declared that the drug is expected to be offered in 2025, and they are working towards having a Pivya intravenous option for use in hospitals for more severe cases.
Pivya should not be administered to patients with hypersensitivity to the group antibacterial agents known as beta-lactam, as stated by the FDA.