NBC News
According to a study published Monday in The Lancet, during an advanced phase clinical trial it was discovered that a pill developed by the GSK company is safe and effective to treat gonorrhea. If approved, it would become a new class of antibiotics to treat sexually transmitted infection in more than two decades.
The pill, called Gepísto, was approved by the Food and Medicines Administration (FDA) in March to treat uncomplicated infections of the urinary tract in women and girls of 12 years or more, the most common type of infection in women. The medicine is sold under the name of Blippa.
A new treatment option is important, experts indicated, because the bacteria that commonly cause Sti (sexually transmitted infections) are becoming more and more resistant to standard antibiotics, which makes treatment difficult.
It is estimated that 82 million new cases of gonorrhea are produced every year, according to GSK. In the United States, notified gonorrhea rates have increased 118% between 2009 and 2021, and in 2022 more than 640,000 cases were notified to the centers for disease control and prevention (CDC, in English).
According to CDC, gonorrhea has developed resistance to almost all antibiotics used for treatment.
If not treated, Gonorrhea can cause serious complications Health, such as inflammation and joint pain, inflammation of the liver and damage to the heart and brain. It can also increase the risk of infertility in women.
Gepípygin is part of a new class of antibiotics called triazaacenaftenos, which act by addressing two key enzymes that gonorrhea needs to copy itself and survive.
In a clinical trial in phase 3 with more than 600 adults and adolescents, it was shown that Gepítidacina successfully treated about 92% of patients when it was taken twice a day, compared to about 91% in a group of patients who received a standard treatment.
The most common side effect were gastrointestinal problems, and almost all those that were notified were “mild or moderate.”
According to the authors of the study, the most important thing is that the pill was effective against strains of the gonorrhea bacteria that are resistant to existing antibiotics.
Dr. Sovrin Shah, an associate professor of Urology at the Mount Sinai hospital in New York that did not participate in the study, described the GSK pill as “a welcome addition.”
“Antibiotic resistant gonorrhea It is a public health problem“Shah said.” The Sti rate is significant in the United States. “
David Harvey, executive director of the National Coalition of Directors of STD (sexually transmitted diseases) said that “we desperately need effective priests to combat gonorrhea,” but noted that generalized employment cuts in federal health agencies, including a laboratory that followed the STI, could hinder the task.
“The recent closure of the CDC STI key laboratory, which helped us to understand which antibiotics are still effective and when we need to use new medications like this, proposes a new important obstacle,” said Harvey.
A GSK spokesman said that the company plans to present the approval before the FDA “in the coming months”, and that a regulatory decision is expected in the second half of the year.
The company assured that it is looking for the approval of Gepípicin as an alternative to first -line therapy when such treatment is inappropriate, such as when a patient is intolerant of existing treatment or is not willing to use it.
In a text that accompanied the study, Magnus Unemo, director of the Division of the World Health Organization that supervises gonorrhea, commented that the GSK pill It is “promising”but added that there will continue to be challenges to maintain gonorrhea as a treatable infection.
UNEMO also emphasized the improvement of prevention, including the promotion of safe sex and the use of condoms, early diagnosis and surveillance.
