The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (RVVC).
The sNDA is supported by data from the multicenter, randomized, double-blind, placebo-controlled phase 3 CANDLE study (ClinicalTrials.gov Identifier: NCT04029116), which evaluated the efficacy and safety of ibrexafungerp in 260 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 or ibrexafungerp 300mg orally twice daily for 1 day every 4 weeks for 6 months (a total of 6 treatment days).
Findings showed that a greater proportion of patients treated with ibrexafungerp met the primary endpoint achieving clinical success (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 (P =.034). The most common adverse reactions reported with ibrexafungerp were headaches, diarrhea, and nausea.
Ibrexafungerp, a triterpenoid antifungal, is currently marketed under the brand name Brexafemme for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis. The sNDA for RVVC prevention has been given a Prescription Drug User Fee Act (PDUFA) target date of November 30, 2022.
- Scynexis announces US Food and Drug Administration acceptance and Priority Review of the supplemental New Drug Application for Brexafemme® (ibrexafungerp tablets) for prevention of recurrent vaginal yeast infections. News release. Scynexis, Inc. Accessed August 1, 2022. https://www.globenewswire.com/news-release/2022/08/01/2489391/0/en/SCYNEXIS-Announces-U-S-Food-and-Drug-Administration-Acceptance-and-Priority-Review-of-the-Supplemental-New-Drug-Application-for-BREXAFEMME-ibrexafungerp-tablets-for-Prevention-of-R.html
- Scynexis Announces submission of supplemental New Drug Application of ibrexafungerp to the US Food and Drug Administration for an expanded indication for the prevention of recurrent vaginal yeast infections. News release. Scynexis, Inc. June 8, 2022. Accessed August 1, 2022. https://www.scynexis.com/news-media/press-releases/detail/293/scynexis-announces-submission-of-supplemental-new-drug