FDA Approves Two New Antibiotics for Gonorrhea

The FDA has approved two new novel oral antibiotics for treating uncomplicated gonorrhea infections. CIDRAP has the news.

Zoliflodacin was approved on December 12, just a day after “release of the full results of a pivotal, multinational phase 3 trial that showed a single dose of the first-in-class antibiotic was noninferior to an injection of ceftriaxone and an oral dose of azithromycin—the standard treatment at the time the trial was conducted.” On December 11, gepotidacin was also approved by the FDA.

This provides “two new oral antibiotic treatment options for one of the world’s most common sexually transmitted infections, following several years of concern about rising resistance to ceftriaxone.” WHO data showed that multidrug-resistant gonorrhea has been “climbing sharply in some countries.” Both the WHO and the CDC have warned that gonorrhea could become untreatable without new antibiotics.

Zoliflodacin is the “first new antibiotic developed solely for gonorrhea in decades.” It is taken orally, which makes it preferable for patients who don’t like injections. It is also easier to store in low-resource settings since it doesn’t need to be refrigerated or mixed. Limiting the antibiotic to gonorrhea infections will also hopefully “minimize excessive use and slow the development of resistance.” Gepotidacin will provide “another alternative oral treatment option for gonorrhea patients.”