Phase III data evaluating Vivjoa in recurrent vulvovaginal candidiasis published in NEJM Evidence
Mycovia Pharmaceuticals announced the publication of positive Phase III data evaluating Vivjoa (oteseconazole) capsules in patients with recurrent vulvovaginal candidiasis (RVVC) in the July edition of NEJM Evidence
Vivjoa is the first and only FDA-approved medication for RVVC indicated to reduce the incidence of RVVC in females with a history of RVVC who are NOT of reproductive potential.
Mycovia’s two global, randomized, double-blind, placebo-controlled Phase III VIOLET studies, which comprised 656 women with RVVC who had experienced three or more symptomatic episodes of vulvovaginal candidiasis (VVC) within the previous 12 months. Of the 652 subjects whose presenting infections were cleared with fluconazole, 435 were randomly assigned to receive 150 mg of oral Vivjoa daily for seven days followed by once weekly for 11 weeks, and 217 were randomly assigned to matching placebo for 12 weeks. Baseline demographics were similar in both trials. Both VIOLET studies met their primary and key secondary endpoints. At the end of the 48-week maintenance period, 93.3% and 96.1% of women with RVVC who received Vivjoa did not have a recurrence, compared to 57.2% and 60.6% of patients who received placebo (P<0.001). among the 22 women treated with vivjoa who experienced an rvvc episode during the 48-week maintenance period, the average time it took to first recurrence of a vvc episode was 45.7 and 47.2 weeks, compared to 27.8 and 33.1 weeks for the 84 women treated with placebo who had a recurrence.
See: "Efficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis." Jack D. Sobel et al. NEJM Evid 2022; 1 (8) Published July 26, 2022 DOI https://doi.org/10.1056/EVIDoa2100055
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