The FDA Just Approved a First-of-Its-Kind Drug for Chronic Yeast Infections
The U.S. Food and Drug Administration (FDA) has approved the first oral antifungal medication, called Vivjoa, to specifically treat recurrent vaginal yeast infections. The administration said in a report that the medication could help stop recurrent vulvovaginal candidiasis (RVVC) for people “who are not of reproductive potential.” Around 5% of people with vaginas deal with RVVC, meaning they get four or more vaginal yeast infections each year, according to the U.S. Office on Women’s Health.
A vaginal yeast infection is extremely uncomfortable and disruptive because it can result in itching and burning of the vulva (the area around the vagina), pain while urinating, pain during sex, and thick vaginal discharge. A yeast infection develops when the fungus Candida, which naturally exists in the vagina, grows excessively. Those who are more susceptible to recurrent vaginal yeast infections include people who are pregnant; people who regularly douche or use vaginal sprays; people who recently took steroids, antibiotics, or high-estrogen birth control; immunocompromised people, such as those with HIV; or people with uncontrolled diabetes. The medication should be taken two days in a row; 14 days after the first dose, it should be taken once a week for 11 weeks, according to Mycovia Pharmaceuticals, the maker of Vivjoa.
The average vaginal yeast infection can usually be treated with over-the-counter antifungal medication, like Monistat or Vagisil, both of which are vaginal creams. The antifungal fluconazole (Diflucan), a tablet that is taken once, is often prescribed to treat yeast infections, though some people can become resistant to the drug over time, according to the Centers for Disease Control and Prevention (CDC). Suppositories, which are inserted into the vagina, are also sometimes used to treat yeast infections.
Historically, people with recurrent vaginal yeast infections haven’t had great treatment options. “Prior to its approval, the FDA-approved treatments on the market were only indicated for the treatment of an acute infection,” Leah. S. Millheiser, MD, FACOG, NCMP, tells SELF. “This approval is significant because, although not that common, recurrent vaginal yeast infections can be very distressing for an individual and can have a negative impact on overall quality of life.”
As we previously mentioned, Vivjoa is only available to certain people who have been diagnosed with RVVC since it is not recommended for people of “reproductive potential.” Studies on animals have shown the drug can potentially cause damage to the fetus if you were to become pregnant while on the medication. According to the FDA, the drug is only recommended for people who are biologically female and postmenopausal or permanently infertile due to tubal ligation, hysterectomy, or other factors.
Oteseconazole, the active ingredient in Vivjoa, inhibits the fungal growth that causes a yeast infection and was designed to treat recurrent infections, specifically. In two global studies, 93.3% and 96.1% of people with RVVC who were treated with Vivjoa did not experience a recurrent yeast infection in close to a year after taking the drug compared to 57.2% and 60.6% of people who were given a placebo. Across the FDA’s three clinical trials conducted before approval, a total of 580 people with RVVC aged between 18 to 44 years old were treated with Vivjoa for three months. Adverse reactions weren’t common: 0.2% of the people treated with Vivjoa reported allergic dermatitis (an allergic reaction that results in an uncomfortable skin rash) and less than 2% experienced headache and nausea. (While these were the most common side effects, the FDA says others are possible, so it’s important to have that discussion with your doctor before moving forward with the medication.)
If you’re not sure whether your yeast infection situation warrants a drug like Vivjoa, talk to your primary care doctor or ob-gyn to see if it might be right for you. You shouldn’t have to put up with constant symptoms—so it’s important to advocate for the care you need and deserve by exploring all your options.