Brexafemme filed with supplemental NDA to the FDA for recurrent vulvovaginal candidiasis.

Brexafemme, approved by the U.S. FDA in June 2021 for the treatment of vulvovaginal candidiasis (VVC), is a novel class of antifungal and the first and only oral fungicidal treatment that can cure a vaginal yeast infection in adults and postmenarchal pediatric patients. If approved for the additional indication, Brexafemme would be the first and only oral non-azole treatment for the prevention of recurrent yeast infections, defined as three or more episodes of VVC in the previous 12 months.

The sNDA submission is based on positive results from the Scynexis global Phase III study (CANDLE) investigating the safety and efficacy of monthly dosing of ibrexafungerp for prevention of RVVC, which showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected, through Week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant (p=0.034). In the study, ibrexafungerp was generally safe and well-tolerated. The most commonly-reported adverse events, headaches and gastrointestinal in nature (i.e., diarrhea, nausea), were mostly mild and generally consistent with the current Brexafemme label.