Mycovia Pharmaceuticals has published new long-term results showing that VIVJOA® (oteseconazole) continues to protect women against recurrent vulvovaginal candidiasis (RVVC) for nearly two years. The data come from the extension phase of the VIOLET Phase 3 program and appear in the Journal of Women’s Health.
VIVJOA is the first and only FDA-approved therapy for RVVC, indicated for post-menopausal women or women not of reproductive potential.
Phase 3 Findings (Original VIOLET Trials)
The VIOLET trials were two global, double-blind, placebo-controlled studies that supported FDA approval in 2022.
Key results:
- Up to 96% of women taking VIVJOA remained infection-free through 48 weeks.
- 61% remained infection-free on placebo.
- P < 0.001, demonstrating statistical superiority.
- Safety profile was comparable to placebo; most common AEs:
- Headache (7.4%)
- Nausea (3.6%)
Long-Term Extension Study (New Data)
Women who had no RVVC episodes during the initial 48 weeks were followed for an additional 48 weeks, bringing total observation to 96 weeks.
- 98% of women originally randomized to VIVJOA remained infection-free through 96 weeks.
- 82% of women originally receiving placebo remained infection-free.
- Result indicates sustained protection for nearly two years after treatment.
Expert Commentary
Investigators highlighted that VIVJOA offers:
- A shorter dosing regimen
- Better long-term outcomes compared with fluconazole
- A meaningful option for women experiencing multiple infections annually (some > 20 episodes pre-study)
Mycovia executives noted that RVVC is often overlooked despite being chronic, painful, and linked to major quality-of-life and emotional burdens.
About RVVC
- Affects 138 million women globally each year.
- Defined as ≥3 symptomatic acute VVC episodes in 12 months.
- Symptoms include itching, burning, inflammation, painful intercourse, and abnormal discharge.
- Causes significant physical, emotional, and economic burden.
About VIVJOA® (oteseconazole)
VIVJOA is an azole antifungal designed to selectively inhibit fungal CYP51, sparing human enzymes and reducing fungal cell growth.
Approved based on three Phase 3 trials:
- VIOLET 1 & 2
- ultraVIOLET (US study)
Total: 875 patients across 232 sites in 11 countries
Safety and Contraindications
VIVJOA is contraindicated in:
- Females of reproductive potential
- Pregnant or lactating women
- Patients with hypersensitivity to oteseconazole
Warnings include potential fetal harm due to long drug-elimination duration.
Common adverse reactions:
- Headache (7.4%)
- Nausea (3.6%)
Drug interaction caution:
- BCRP inhibitor → may increase exposure to drugs like rosuvastatin.
About Mycovia
Mycovia focuses on therapies for unmet infectious-disease needs.
VIVJOA is its first FDA-approved therapy. The company is also developing oral fungal inhibitors targeting multi-drug-resistant pathogens.
