FDA Approves First Treatment for Recurrent Yeast Infections

The Food and Drug Administration (FDA) has approved Vivjoa, an antifungal medication that is designed to reduce recurrent yeast infections in women with a history of the condition.

Vivjoa, which is a brand name for oral oteseconazole capsules, is designed for females with a history of recurrent vulvovaginal candidiasis (RVVC) who are infertile or post-menopausal. This is the first medication of its kind to treat chronic yeast infections.

The drug will be available through a prescription.

RVVC, which is also known as chronic yeast infection, is defined as having three or more symptomatic acute episodes of a yeast infection within 12 months. Symptoms include vaginal itching, burning, irritation, and inflammation. Some women may have abnormal vaginal discharge, pain during sex, and painful urination.

“Chronic yeast infections can be tricky to treat,” Jennifer Wider, MD, women’s health expert, told Verywell. “Having more options, including an effective medication for women who are either postmenopausal or infertile, will provide relief for millions of women who suffer from this common condition.”

The news is “very exciting,” Christine Greves, MD, a board-certified OB-GYN at the Winnie Palmer Hospital for Women and Babies in Florida, told Verywell. “There are quite a few women who suffer from recurrent yeast infections.”

Road to Approval

The approval of Vivjoa is based on the results of three phase 3 clinical trials of the medication that studied 875 patients at 232 sites across 11 countries.

The global studies showed that 93.3% and 96.1% of women with RVVC who received Vivjoa didn’t have another vaginal yeast infection during the 48-week maintenance period. By comparison, just 57.2% and 60.6% of patients who received a placebo did not develop another vaginal yeast infection during that time.

In the U.S. study, 89.7% of women with RVVC who received Vivjoa cleared their initial yeast infection and did not experience another one during the 50-week maintenance period compared to 57.1% of those who received the anti-fungal medication fluconazole, followed by a placebo.

What to Know About Vivjoa

Vivjoa is the only drug that is specifically approved to treat recurrent yeast infections in select people. Prior to the approval, recurrent yeast infections were treated with longer courses of commonly used antifungal medications, including miconazole, clotrimazole, and fluconazole, Wider said.

“There are other options than Vivjoa to treat recurrent yeast infections, but none with the statistics that this medication seems to offer,” Greves said.

How to Take Vivjoa

There are two different ways to take Vivjoa, which is a capsule dispensed by a prescription: on its own or with fluconazole.

When Vivjoa is taken alone, it’s dispensed as a single 600 mg dose on day one and a 450 mg dose on day two. On day 14, patients are advised to take a 150 mg dose of Vivjoa every week for 11 weeks.

If Vivjoa is taken with fluconazole, patients will take 150 mg of fluconazole on days one, four, and seven, followed by 150 mg of Vivjoa daily on days 14 through 20. On day 28, the patient will take 150 mg of Vivjoa once a week for 11 weeks.

Accessibility and Limitations of Vivjoa

Vivjoa is designed only for people who are infertile or post-menopausal. It should not be taken by people who are fertile—animal studies suggest that the medication may cause fetal harm. It’s also not advised for pregnant and lactating people due to potential risks to the fetus or breastfed infant.

Known Side Effects

The most frequently reported side effects included headache (in 7.4% of patients) and nausea (in 3.6% of patients).

Vivjoa should be covered by health insurance, but you’ll need to check with a healthcare provider.