Brexafemme (ibrexafungerp), a new antifungal medication, was approved by the FDA to treat vaginal yeast infections, biotech company Scynexis announced Wednesday.
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 new class of structurally distinct glucan synthase inhibitors.
“We are pleased to bring this much needed innovation to the antifungal field and to offer a new one-day oral antifungal treatment for vaginal yeast infections to millions of women who could benefit from a new therapeutic option,” said Scynexis chief medical officer David Angulo, MD, in a press release.
Angulo added that Brexafemme has a distinct fungicidal mechanism of action that kills a broad range of Candida species — including some strains resistant to azole medications.
About 75% of all women develop at least one vaginal yeast infection during their lifetime, and nearly half experience multiple infections, the drug manufacturer noted. Prior to the brexafemme approval, oral fluconazole was the only other oral antifungal medication approved to treat vulvovaginal candidiasis.
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 (two 300 mg tablets around 12 hours apart) or a placebo.
The first trial (VANISH-303) included 376 patients from 28 U.S. medical centers. 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 and may cause fetal harm based on pre-clinical data. 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 to 150 mg twice a day for one day, 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.
Brexafemme will launch in the second half of this year, and Scynexis has partnered with Amplity Health to sell the medication.
While brexafemme is the first FDA-approved indication of ibrexafungerp, Angulo added that the biotech company is investigating ibrexafungerp to prevent recurrent vaginal yeast infections in an additional clinical trial. They expect to submit a supplemental New Drug Application in the first half of 2022, he said.