Phase 3 study evaluating the safety and efficacy of oteseconazole in the treatment of recurrent vulvovaginal candidiasis and acute vulvovaginal candidiasis infections

• Published in: American journal of obstetrics and gynecology 2022-12, Vol.227 (6), p.880.e1-880.e11
• Main Authors: Martens, Mark G., Maximos, Bassem, Degenhardt, Thorsten, Person, Karen, Curelop, Stacey, Ghannoum, Mahmoud, Flynt, Amy, Brand, Stephen R.
• Format: Article
• Language: English
• Subjects: Administration, Oral; antifungal; Antifungal Agents - adverse effects; Candidiasis, Vulvovaginal - chemically induced; Candidiasis, Vulvovaginal - drug therapy; Female; Fluconazole - adverse effects; Fluconazole - therapeutic use; Humans; induction therapy; Infections; maintenance therapy; oteseconazole; prophylaxis; recurrent vulvovaginal candidiasis; RVVC; VT-1161; yeast infection
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2022.07.023

Recurrent vulvovaginal candidiasis affects nearly 138 million women globally each year. In the United States, fluconazole is considered the standard of care for acute vulvovaginal candidiasis, but until recently there was no US Food and Drug Administration–approved drug for the treatment of recurrent vulvovaginal candidiasis. Oteseconazole is a novel oral selective inhibitor of fungal lanosterol demethylase (sterol 14α-demethylase cytochrome P450, an enzyme required for fungal growth) approved for the treatment of recurrent vulvovaginal candidiasis. This study was conducted to evaluate the efficacy and safety of oral oteseconazole (VT-1161) in the prevention of recurrent culture-verified acute vulvovaginal candidiasis episodes through 50 weeks in participants with recurrent vulvovaginal candidiasis and to compare the efficacy of oteseconazole and fluconazole in the treatment of the presenting acute vulvovaginal candidiasis episode. Women and postmenarcheal girls aged ≥12 years with a history of recurrent vulvovaginal candidiasis (N=219) were enrolled at 38 US sites. Eligible participants presenting with an active vulvovaginal candidiasis infection entered an induction phase in which they were randomly assigned 2:1 to receive 600 mg oral oteseconazole on day 1 and 450 mg on day 2, with matching placebo capsules, or to 3 sequential 150-mg oral doses (once every 72 hours) of fluconazole, with matching placebo capsules. Following the 2-week induction phase, the 185 participants with resolved acute vulvovaginal candidiasis infection (a clinical signs and symptoms score of