FDA OKs Novel Antifungal for Vaginal Yeast Infections
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Brexafemme (ibrexafungerp), a new antifungal medication, was approved by the FDA to treat vaginal yeast infections, biotech company Scynexis announced.

The 1-day medication is the only non-azole oral treatment for vulvovaginal candidiasis and marks the first approved drug in a new antifungal class in more than 20 years. Ibrexafungerp is the first representative of a new class of structurally distinct glucan synthase inhibitors. Brexafemme has a distinct fungicidal mechanism of action that kills a broad range of Candida species, including strains resistant to azole medications.

The FDA granted brexafemme both Qualified Infectious Disease Product and Fast-Track designations for treating vaginal yeast infections and preventing recurrent vaginal yeast infections. Brexafemme's approval is based on two Phase III clinical trials showing that the drug was effective and well-tolerated in patients with vaginal yeast infections. In the VANISH trials, women with acute episodes of vulvovaginal candidiasis were randomized 2:1 to receive either a single-day regimen of ibrexafungerp or a placebo.

The first trial included 376 patients. In a modified intent-to-treat analysis, the manufacturer reported 50.5% of women in the ibrexafungerp group met the primary endpoint of clinical cure at the day 10 test-of-cure visit, which was statistically significant superiority compared to placebo. In VANISH-306, 63% of the ibrexafungerp group met the primary endpoint, the manufacturer said.

Brexafemme is contraindicated during pregnancy. The drug is also not indicated for patients with a history of hypersensitivity reactions. When administering with strong CYP3A inhibitors, the dose should be reduced, and administering with strong CYP3A inducers should be avoided.

The most common adverse events in the clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

While brexafemme is the first FDA-approved indication of ibrexafungerp, the author added that the biotech company is investigating ibrexafungerp to prevent recurrent vaginal yeast infections in an additional clinical trial.

Source: https://ir.scynexis.com/press-releases/detail/240/scynexis-announces-fda-approval-of-brexafemme