FDA Approves First and Only Medication to Treat Chronic Yeast Infections

For some people who experience chronic yeast infections, relief may be in sight: The U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind antifungal medication to treat the recurrent condition.

The drug, Vivjoa (oteseconazole capsules), is meant for people with internal genitals, who have a history of recurrent vulvovaginal candidiasis (RVVC)—that equates to having three or more yeast infections within a 12-month period. Only people who are postmenopausal or infertile are approved to use Vivjoa; animal studies suggest the drug may cause fetal harm, so people who are pregnant, breastfeeding, or may become pregnant should not take it.

Still, the new treatment option—the first one in nearly 20 years—is a welcomed addition among patients and prescribers alike.

"Treatment for recurrent yeast infections has lagged, with no new therapeutic options for almost two decades, Hayley Miller, MD, Stanford Medicine Obstetrics and Gynecology and Maternal-Fetal Medicine Fellow, told Health. "The current management strategies for recurrent yeast infections include long durations of fluconazole use, and although safe, compliance and patient satisfaction are not optimal."

Here's what to know about the new drug, including how it works, and who it is—and isn't—meant for.

What Are Chronic Yeast Infections?

Yeast infections—known technically as vaginal or vulvovaginal candidiasis—occur when the fungus candida albicans disrupts the typical balance of yeast and bacteria in the vagina. Symptoms include vaginal itching, burning, inflammation, and irregular discharge. Pain with urination and sexual intercourse are commonly reported, as well.

People who have a weakened immune system, are pregnant, have recently taken antibiotics, have diabetes, or use oral contraceptives are more likely to experience yeast infections. About 75% of people with internal genitals will have at least one yeast infection in their lifetime—9% will go on to develop RVVC.

Typically, oral antifungal drugs and ointments can cure mild, isolated yeast infections, but people who have RVVC have traditionally had to take antifungal drugs—both in oral and topical form—for longer periods of time for the chance to see long-term results. Even then, recurrence rates are high.

"In women with recurrent yeast infections, a considerable population globally, treatment needs are currently unmet by available topical antifungal and oral agents, including fluconazole," said Dr. Miller, adding that these treatments are very inconvenient for people with recurrent yeast infections; long-term use of topical antifungals are used infrequently, leaving many people having to deal with recurrence.

How Vivjoa Works

The FDA based the drug's approval off of three clinical trials that evaluated its efficacy and safety in nearly 900 patients at more than 200 medical sites across 11 countries. Two of the studies were done globally, the other was U.S.-based.

In the global studies, 93% and 96% of the participants—whom drugmaker Mycovia identified as women—did not have a recurrence of their RVVS during the 48-week trial period. In the placebo group, only 57% and 60% of participants did not experience recurrent infection.

In the U.S.-based study, close to 90% of those with RVVC who took Vivjoa cleared the infection and did not have a recurrent infection in the 50-week study period, compared to 57% with RVVC who received fluconazole followed by placebo.

"This particular medication, Vivjoa, apparently has high efficacy with low recurrence risk—a boon to that subsection of the population so plagued with recurrent vulvovaginal yeast infections," Kecia Gaither, MD, MPH, FACOG, a double board-certified ob-gyn and maternal fetal medicine specialist and director of perinatal services at NYC Health + Hospitals/Lincoln, told Health.

The drug, which works by inhibiting fungal growth, is intended for oral use, and it can be used alone or in combination with fluconazole. For Vivjoa-only use, the drug is taken orally once for two days, and then starting on day 14, it's taken once-weekly for 11 weeks. When taken alongside fluconazole, that drug is taken on days one, four, and seven, and then starting on day 14, Vivjoa is taken once a day for a week, and then once a week for 11 weeks.

The most common side effects of Vivjoa in clinical trials included headache (7.4%) and nausea (3.6%).

Who Shouldn’t Take Vivjoa

The drug is not intended for people who are pregnant, lactating, or capable of reproducing. That's because, according to the drug's prescribing information, animal studies suggest Vivjoa can cause fetal harm.

This data comes from a study conducted on rats, in which the medication caused ocular abnormalities in offspring—including cataracts, opacities, hemorrhages, and optic nerve atrophy.

"The medication is a teratogen, meaning it can result in birth defects, therefore it cannot be used in [people] who have the ability to get pregnant—this includes [people] using contraception—and those breastfeeding," Terri Huynh, MD, gynecologic surgeon with Yale Medicine and assistant professor at Yale School of Medicine, told Health.

The drug takes a long time to be cleared by the body, which is why it is not meant for anyone with reproductive potential. The medication was not studied in adolescents, as the drug has been deemed unsafe in this age group.

Vivjoa is also contraindicated for people who are allergic or sensitive to oteseconazole or other ingredients in the drug.

According to Dr. Huynh, anyone experiencing recurrent yeast infections should consult with a healthcare provider. Before starting treatment, it's crucial to confirm the diagnosis and obtain a yeast culture, as certain stains may be better treated with alternative therapies.

Though Vivjoa is intended for a very specific subset of women, reproductive health specialists are glad to see a treatment option available for a condition that plagues many women.

"This is an important development because medical issues that impact only women are often underfunded and overlooked. It is refreshing to see novel therapy for conditions that afflict women," Dr. Huynh said. "It is great to have additional tools to offer persons suffering from recurrent vaginitis symptoms."