Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo‐controlled superiority study (VANISH 306)

Objective To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment. Design Global phase 3, randomised, placebo‐controlled superiority study. Setting Study sites in the USA (n = 19) and Bulgaria (n = 18). Population Female patients aged ≥12 years with acute VVC and a vulvovaginal signs and symptoms (VSS) score ≥4 at baseline. Methods Patients were randomly assigned 2:1 to ibrexafungerp (300 mg twice for 1 day) or placebo. Main outcome measures The primary endpoint was the percentage of patients with a clinical cure (VSS = 0) at the test‐of‐cure visit (day 11 ± 3). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS ≤1) at test‐of‐cure visit, and complete resolution of symptoms at follow‐up visit (day 25 ± 4). Results At the test‐of‐cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119/188] versus 44.0% [37/84]; P = 0.007), mycological eradication (58.5% [110/188] versus 29.8% [25/84]; P