It is the first and only FDA-approved medication for recurrent vulvovaginal candidiasis (RVVC)—the medical term for chronic yeast infections.
The approval is based on data from three Phase 3 trials, which included 875 people in 11 countries. In the first two trials, over 90% of women taking Vivjoa did not experience a yeast infection recurrence over the 48-week period, compared to roughly 60% of the placebo groups. During the third trial, which lasted 50 weeks, 89.7% of women avoided a recurrence.
Seventy-one of the participants took place in a 48-week extension period, during which 85% of them continued to not experience yeast infections.
While the approval is novel, it’s not for everyone. The approval does not extend to anyone who is “of reproductive potential”—those who are pregnant or able to get pregnant.
What Is Recurrent Vulvovaginal Candidiasis?
RVVC is a worsening or relapsing vaginal fungal infection that occurs three or more times in one year, June Gupta, NP, Senior Director of Medical Services at Planned Parenthood Federation of America, told Verywell via email.
Most women—about 75%—will experience a yeast infection at some point. This condition is referred to as vulvovaginal candidiasis (VVC) by medical professionals.
For less than 5% of people, those yeast infections will occur frequently enough to be deemed RVVC.
How Does It Work?
Like other antifungal drugs, Vivjoa works by entering the cell wall of yeast and slowly breaking it down over time.
“It works by inhibiting an enzyme that the fungus needs to make its protective outer covering,” Kecia Gaither, MD, MPH, FACOG, Director of Perinatal Services/Maternal Fetal Medicine at NYC Health, told Verywell via email. “It also causes a buildup of toxic substances within the fungus, causing its death.”
Gaither said that on its own, the medication should be taken orally for a total of 12 weeks. But if it’s taken with another antifungal medication like fluconazole, then the dosage lasts 14 weeks.
Who Can’t Take Vivjoa?
People who have a chance of getting pregnant can’t take Vivjoa because it can cause teratogenic effects: functional or physical defects in an embryo or fetus.
“This medication stays in your system for two years,” G. Thomas Ruiz, MD, OB-GYN Lead at MemorialCare Orange Coast Medical Center in Fountain Valley, California, told Verywell. “If you get pregnant with this chemical in your body, that will affect the developing fetus. [Vivjoa] is now strictly approved for menopausal women or women who have had a sterilization procedure.”
In addition, people with renal or liver issues should not take the medication.
Why FDA Approval Matters
Ruiz describes the drug’s approval as life-changing.
“If you are a woman with chronic vulvovaginal candidiasis and it doesn’t get better, it can be very uncomfortable because of the chronic itching and scratching,” he said. “Sometimes, an individual can scratch so much that the skin starts to break down. For women who are able to take this medication, it’s probably life-changing and a godsend.”
Although not all people who experience RVVC will be eligible for Vivjoa, Gupta said that “having more treatment options that can help people manage their sexual and reproductive health is a step in the right direction.”
