Biopharmaceutical company Mycovia Pharmaceuticals Inc announced on Tuesday that long-term efficacy results from an extension study of the VIOLET Phase 3 clinical programme, which evaluated VIVJOA (oteseconazole) capsules in women with recurrent vulvovaginal candidiasis (RVVC), has been published in Journal of Women's Health.
The product is the first and only available FDA-approved therapy for RVVC, or chronic yeast infections, in post-menopausal women or women who are not of reproductive potential.
The VIOLET studies, two Phase 3 multi-centre, multi-national, double-blind, randomised, placebo-controlled clinical trials, assessed the efficacy and safety of VIVJOA in women with RVVC and provided pivotal data supporting US approval of VIVJOA for RVVC in 2022.
VIVJOA was demonstrated to be statistically superior to placebo in reducing culture-verified VVC infections through 48 weeks, with up to 96% of women receiving VIVJOA remaining infection free compared to 61% receiving placebo.
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