Chronic Yeast Infection Therapy Trial Produces Positive Outcomes

 Chronic Yeast Infection Therapy Trial Produces Positive Outcomes

Mycovia, a biopharmaceutical company, released topline results from evaluating VIVJOA™ (oteseconazole) capsules in patients suffering from recurrent vulvovaginal candidiasis (RVVC).

Also known as chronic yeast infection, RVVC is a distinct condition from vulvovaginal candidiasis (VVC) and is defined by the Centers for Disease Control and Prevention as three or more symptomatic episodes of yeast infection in 12 months. 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.

The VIOLET extension study followed the successful completion of Mycovia’s two global, pivotal Phase 3 VIOLET studies to assess the long-term protective profile of VIVJOA given its pharmacokinetic profile and extended half-life beyond the original 48-week study duration. U.S. participants in the VIOLET studies treated with a 12-week course of VIVJOA who did not experience a VVC episode during the 48-week study were offered the opportunity to participate in an extension study, during which they were monitored for an additional 48 weeks (96 weeks total).

Of the 71 patients enrolled in the observational extension study, 85% completed 96 weeks without a recurrent VVC episode. The average time without recurrence was 92 weeks. The authors concluded that VIVJOA may play an important role in providing long-term reduction in the incidence of disease recurrence for women with RVVC.

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