General Information

Vivjoa (oteseconazole) is an azole antifungal.

Vivjoa is specifically indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Vivjoa is suppled as capsules for oral administration.

There are two recommended Vivjoa dosage regimens: a Vivjoa-only regimen and a Fluconazole/ Vivjoa regimen. Use one of the following two dosage regimens:

Vivjoa-only Dosage Regimen:

On Day 1: Administer Vivjoa 600 mg (as a single dose), then

On Day 2: Administer Vivjoa 450 mg (as a single dose), then

Beginning on Day 14: Administer Vivjoa 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12).

Fluconazole/Vivjoa Dosage Regimen:

prescribe fluconazole and:

On Day 1, Day 4, and Day 7: Administer fluconazole 150 mg orally, then

On Days 14 through 20: Administer Vivjoa 150 mg once daily for 7 days, then

Beginning on Day 28: Administer Vivjoa 150 mg once a week (every 7 days) for 11 weeks (Weeks 4 through 14).

Mechanism of Action

Vivjoa (oteseconazole) is an azole metalloenzyme inhibitor targeting the fungal sterol, 14α demethylase (CYP51), an enzyme that catalyzes an early step in the biosynthetic pathway of ergosterol, a sterol required for fungal cell membrane formation and integrity. Inhibition of CYP51 results in the accumulation of 14-methylated sterols, some of which are toxic to fungi. Through the inclusion of a tetrazole metal-binding group, oteseconazole has a lower affinity for human CYP enzymes.

Clinical Trial Results

FDA approval was based upon the positive results from three Phase 3 trials of oteseconazole – two global, pivotal VIOLET studies and one U.S.-focused ultraVIOLET study, including 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. In the 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.