Vivjoa FDA Approval History
Last updated by Judith Stewart, BPharm on April 29, 2022.
FDA Approved: Yes (First approved April 26, 2022)
Brand name: Vivjoa
Generic name: oteseconazole
Dosage form: Capsules
Company: Mycovia Pharmaceuticals, Inc.
Treatment for: Vaginal Yeast Infection
Vivjoa (oteseconazole) is an oral azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
- Recurrent vulvovaginal candidiasis (RVVC) is defined as three or more symptomatic acute episodes of yeast infection per year.
- Oteseconazole is a highly selective inhibitor of fungal CYP51 which works by inhibiting fungal growth. It is designed to have fewer side effects and improved efficacy as compared with currently available antifungal agents.
- The FDA approval for Vivjoa was based upon the positive results from three Phase 3 trials of 875 patients at 232 sites across 11 countries. In the two global VIOLET studies, 93.3% and 96.1% of women with RVVC who received Vivjoa did not have a recurrence for the 48-week maintenance period compared to 57.2% and 60.6% of patients who received placebo (p <0.001). In the U.S.-focused ultraVIOLET study, 89.7% of women with RVVC who received Vivjoa cleared their initial yeast infection and did not have a recurrence for the 50-week maintenance period compared to 57.1% of those who received fluconazole followed by placebo (p <0.001).
- Vivjoa capsules are administered orally with food. There are two recommended dosage regimens:
- Vivjoa-only regimen: once daily for 2 days then once weekly starting day 14 for 11 weeks (weeks 2 through 12)
- Fluconazole/Vivjoa regimen: Fluconazole once daily on days 1,4, and 7 then Vivjoa once daily on days 14-20, and once weekly starting day 28 for 11 weeks (weeks 4 through 14).
- Vivjoa may cause fetal harm and is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant.
- Common adverse reactions include headache and nausea.
Development timeline for Vivjoa
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