The Food and Drug Administration (FDA) has approved Brexafemme® (ibrexafungerp) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in adult and postmenarchal 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 randomized, double-blind, placebo-controlled phase 3 CANDLE study (ClinicalTrials.gov Identifier: NCT04029116), which evaluated the efficacy and safety of ibrexafungerp in female patients with RVVC (defined as 3 or more episodes of VVC in the previous 12 months).
All patients received oral fluconazole for their acute episode present at screening. Patients who responded to fluconazole treatment were randomly assigned to receive placebo (n=130) or ibrexafungerp 300mg orally twice daily for 1 day every 4 weeks for 6 months (a total of 6 treatment days; n=130).
Findings showed that a statistically significantly greater proportion of patients treated with ibrexafungerp achieved clinical success (primary endpoint; defined as having no recurrence at all, either culture-proven, presumed or suspected) through week 24 compared with those who received placebo (65.4% vs 53.1%; P =.02); these results were sustained over a 3-month follow-up period (57.7% vs 46.2%; P =.034).
The most common adverse reactions reported with ibrexafungerp were headache, abdominal pain, diarrhea, nausea, urinary tract infection and fatigue. Brexafemme use is contraindicated in pregnancy because it may cause fetal harm. Reassessment of pregnancy status prior to each dose is recommended when used for RVVC.
Brexafemme is also indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis.
- SCYNEXIS announces FDA approval of second indication for Brexafemme® (ibrexafungerp tablets) for reduction in incidence of recurrent vulvovaginal candidiasis. News release. December 1, 2022. https://www.globenewswire.com/news-release/2022/12/01/2565906/0/en/SCYNEXIS-Announces-FDA-Approval-of-Second-Indication-for-BREXAFEMME-ibrexafungerp-tablets-for-Reduction-in-Incidence-of-Recurrent-Vulvovaginal-Candidiasis.html.
- Brexafemme. Package insert. SCYNEXIS; 2022. Accessed December 1, 2022. https://www.brexafemme.com/sites/default/files/2022-11/prescribing-information.pdf.