Health and Me

Itisha Arya

FDA Clears First New Gonorrhea Drug In 30 Years Amid Growing Antibiotic Resistance

fda clears gonorrhea drug

<span>Gonorrhea</span> poses a far more serious challenge than many realise. Over the years, doctors treating the infection have seen their treatment choices steadily shrink. The bacteria responsible, Neisseria gonorrhoeae, has repeatedly adapted to antibiotics, rendering many once-reliable drugs ineffective. As a result, clinicians have been forced to depend heavily on a single injectable medication, a situation that has raised growing concern.

That dependence is becoming increasingly risky. Data from the US Centers for Disease Control and Prevention show that reported cases of gonorrhea, chlamydia, and syphilis have climbed by nearly 90% since 2004. In 2023 alone, the country recorded more than 2.4 million cases of sexually transmitted infections.

<h2>FDA Clears First New Gonorrhea Drug In 30 Years</h2>

This month, however, marked a significant shift. The US Food and Drug Administration approved two new oral antibiotics to treat gonorrhea: <span>zoliflodacin</span> and <span>gepotidacin</span>. These approvals represent the first entirely new gonorrhea treatments in more than three decades.

“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Dr Adam Sherwat of the FDA in an official statement.

<h2>Why Gonorrhea Has Become Harder to Treat</h2>

If left untreated, gonorrhea can lead to serious complications, including pelvic inflammatory disease, infertility, and in rare cases, infections that spread to the joints or bloodstream, as per Cleveland Clinic. Many people experience no symptoms at all, allowing the infection to spread quietly. Despite years of research, there is still no licensed vaccine, leaving antibiotics as the primary line of defence.

<h2>What the FDA’s Decision Changes</h2>

The newly approved treatments offer a fresh sense of hope. Zoliflodacin, developed by the nonprofit Global Antibiotic Research and Development Partnership in collaboration with Innoviva Specialty Therapeutics, is designed as a single-dose oral medication. Gepotidacin, developed by GSK, is taken in two doses and is also approved for treating certain urinary tract infections.

Both medicines eliminate the need for injections, a shift that could make treatment simpler and more accessible, particularly in settings where access to clinics is limited.

<h2>FDA Clears First New Gonorrhea Drug: How the Two New Medicines Work</h2>

As per Medscape, clinical trial results for both drugs have been encouraging. Zoliflodacin was tested in a large international study involving more than 900 participants across Europe, Africa, Asia, and the US. The drug successfully cured about 90.9% of patients, a rate comparable to the 96.2% success rate of the current injectable standard. Most reported side effects were mild.

Gepotidacin showed similarly strong results in a separate Phase 3 trial that included around 600 patients from six countries. The cure rate reached 92.6%. Some participants reported digestive issues, but these effects were generally described as mild.

Importantly, both medications were effective against strains of gonorrhea that no longer respond to older antibiotics. That said, public health experts stress that these drugs are not a permanent solution.

“Bacteria are smart. They can pass resistant mechanisms between each other,” said Dr Manica Balasegaram of the Global Antibiotic Research and Development Partnership, speaking to CNN.

<h2>Why Experts Say Caution Is Still Needed</h2>

Several uncertainties remain. Neither drug has yet shown strong effectiveness against throat infections, known as pharyngeal gonorrhea, which are more difficult to detect and treat. There is also ongoing debate about how best to use the new medications. Some experts argue they should be reserved as last-line treatments, while others believe earlier use could help slow resistance.

Dr Tereza Kasaeva of the World Health Organization described the approvals as “an important and timely development” amid rising global infection rates and limited treatment options, according to The Guardian.

For now, the new drugs provide much-needed breathing room. Whether that progress holds will depend on careful prescribing and close monitoring of how resistance evolves.

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Gonorrhea poses a far more serious challenge than many realise. Over the years, doctors treating the infection have seen their treatment choices steadily shrink. The bacteria responsible, Neisseria gonorrhoeae, has repeatedly adapted to antibiotics, rendering many once-reliable drugs ineffective. As a result, clinicians have been forced to depend heavily on a single injectable medication, a situation that has raised growing concern.That dependence is becoming increasingly risky. Data from the US Centers for Disease Control and Prevention show that reported cases of gonorrhea, chlamydia, and syphilis have climbed by nearly 90% since 2004. In 2023 alone, the country recorded more than 2.4 million cases of sexually transmitted infections.FDA Clears First New Gonorrhea Drug In 30 YearsThis month, however, marked a significant shift. The US Food and Drug Administration approved two new oral antibiotics to treat gonorrhea: zoliflodacin and gepotidacin. These approvals represent the first entirely new gonorrhea treatments in more than three decades.“These approvals mark a significant milestone for treatment options for patients with uncomplicated urogenital gonorrhea,” said Dr Adam Sherwat of the FDA in an official statement.Why Gonorrhea Has Become Harder to TreatIf left untreated, gonorrhea can lead to serious complications, including pelvic inflammatory disease, infertility, and in rare cases, infections that spread to the joints or bloodstream, as per Cleveland Clinic. Many people experience no symptoms at all, allowing the infection to spread quietly. Despite years of research, there is still no licensed vaccine, leaving antibiotics as the primary line of defence.What the FDA’s Decision ChangesThe newly approved treatments offer a fresh sense of hope. Zoliflodacin, developed by the nonprofit Global Antibiotic Research and Development Partnership in collaboration with Innoviva Specialty Therapeutics, is designed as a single-dose oral medication. Gepotidacin, developed by GSK, is taken in two doses and is also approved for treating certain urinary tract infections.Both medicines eliminate the need for injections, a shift that could make treatment simpler and more accessible, particularly in settings where access to clinics is limited.FDA Clears First New Gonorrhea Drug: How the Two New Medicines WorkAs per Medscape, clinical trial results for both drugs have been encouraging. Zoliflodacin was tested in a large international study involving more than 900 participants across Europe, Africa, Asia, and the US. The drug successfully cured about 90.9% of patients, a rate comparable to the 96.2% success rate of the current injectable standard. Most reported side effects were mild.Gepotidacin showed similarly strong results in a separate Phase 3 trial that included around 600 patients from six countries. The cure rate reached 92.6%. Some participants reported digestive issues, but these effects were generally described as mild.What the Trial Results ShowImportantly, both medications were effective against strains of gonorrhea that no longer respond to older antibiotics. That said, public health experts stress that these drugs are not a permanent solution.“Bacteria are smart. They can pass resistant mechanisms between each other,” said Dr Manica Balasegaram of the Global Antibiotic Research and Development Partnership, speaking to CNN.Why Experts Say Caution Is Still NeededSeveral uncertainties remain. Neither drug has yet shown strong effectiveness against throat infections, known as pharyngeal gonorrhea, which are more difficult to detect and treat. There is also ongoing debate about how best to use the new medications. Some experts argue they should be reserved as last-line treatments, while others believe earlier use could help slow resistance.Dr Tereza Kasaeva of the World Health Organization described the approvals as “an important and timely development” amid rising global infection rates and limited treatment options, according to The Guardian.For now, the new drugs provide much-needed breathing room. Whether that progress holds will depend on careful prescribing and close monitoring of how resistance evolves.