The Food and Drug Administration (FDA) has approved Brexafemme® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis in adults and post-menarchal pediatric females.
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids. It has been shown to have broad spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.
The approval was based on data from the multicenter, randomized, double-blind, placebo-controlled phase 3 VANISH-303 (ClinicalTrials.gov Identifier: NCT03734991) and VANISH-306 (ClinicalTrials.gov Identifier: NCT03987620) trials, which compared the efficacy and safety of ibrexafungerp to placebo in female patients aged 12 years and older with acute vulvovaginal candidiasis. The primary endpoint for both trials was clinical cure, defined as complete resolution (score of 0) of all signs and symptoms at the test-of-cure (TOC) visit on day 10; key secondary endpoints included mycological eradication at TOC and complete clinical response at follow-up.
Findings from VANISH-303 showed that clinical cure at the TOC visit was 50% with ibrexafungerp vs 28% with placebo (difference 22%; 95% CI, 10.2-32.8; P=.001). Mycological eradication and complete clinical response at follow-up was observed in 49.5% and 59.5% of patients treated with ibrexafungerp, respectively, vs 19% and 44% for placebo (P<.001 and P=.007, respectively).
Findings from VANISH-306 showed that clinical cure at the TOC visit was 63.5% with ibrexafungerp vs 44.9% with placebo (difference 18.6%; 95% CI, 6.0-30.6; P=.009). Mycological eradication and complete clinical response at follow-up was observed in 58.7% and 72.5% of patients treated with ibrexafungerp, respectively, vs 29.2% and 49.4% for placebo (P<.001 and P=.006, respectively).
The most frequent adverse reactions reported were diarrhea, nausea, abdominal pain, dizziness, and vomiting. Based on findings from animal studies, Brexafemme use is contraindicated in pregnancy because it may cause fetal harm.
Brexafemme is supplied as 150mg tablets in 4-count blister packs and is expected to be available in the second half of 2021. The Company will also submit a supplemental New Drug Application for ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis in the first half of 2022.
- Scynexis announces FDA approval of Brexafemme® (ibrexafungerp tablets) as the first and only oral non-azole treatment for vaginal yeast infections. [press release]. Jersey City, NJ: Scynexis, Inc.; June 2, 2021.
- Brexafemme [package insert]. Jersey City, NJ: Scynexis, Inc.; 2021.