The following is a summary of “A phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of once-monthly oral ibrexafungerp to prevent recurrent vulvovaginal candidiasis (VVC),” published in the FEBRUARY 2023 issue of Obstetrics and Gynecology by Goje O, et al.

Oral ibrexafungerp has recently been approved for treating acute vulvovaginal candidiasis (VVC). For a study, researchers presented the results from a Phase 3 trial that evaluated the efficacy of ibrexafungerp as a monthly preventative treatment for recurrent VVC. 

The trial enrolled eligible patients with recurrent VVC and culture-confirmed Candida spp. infection at baseline, who were randomized 1:1 to receive either oral ibrexafungerp 300 mg BID for a single day or a placebo. The treatments were repeated once every 4 weeks for a total of 6 single-day treatments. The study’s primary objective was to measure the percentage of patients with no mycologically proven, presumed, or suspected recurrence (all randomized ITT subjects) at week 24, which was 4 weeks after the last dose. The subjects were also assessed for an additional 12 weeks to week 36 for VVC recurrence. Efficacy was further assessed in the per-protocol population (patients who were culture positive at baseline and had no mycologically proven recurrence at Weeks 24 and 36).

The study results showed that ibrexafungerp has potential efficacy as a once-monthly preventative treatment in preventing recurrent VVC. 

Common adverse events reported in the ibrexafungerp group were gastrointestinal intolerance and headache. According to the study, ibrexafungerp, which is used once per month, may be effective in preventing recurrent VVC.

Reference: ajog.org/article/S0002-9378(22)00990-5/fulltext