FDA Approves First and Only Medication to Treat Chronic Yeast Infections

The antifungal is intended for use in postmenopausal or infertile women with a history of recurrent infections.

In a significant breakthrough for individuals dealing with recurrent yeast infections, the U.S. Food and Drug Administration (FDA) has given the green light to an innovative antifungal medication known as Vivjoa (oteseconazole capsules). This groundbreaking drug is specifically designed to address the needs of those with a history of recurrent vulvovaginal candidiasis (RVVC), a condition characterized by the occurrence of three or more yeast infections within a 12-month period. However, it’s important to note that Vivjoa is approved exclusively for postmenopausal or infertile individuals, as animal studies have suggested potential fetal harm. As such, pregnant, breastfeeding, or potentially pregnant individuals should avoid its use.

The introduction of Vivjoa, the first of its kind in nearly two decades, has been welcomed with enthusiasm by both patients and healthcare providers. Dr. Hayley Miller, an Obstetrics and Gynecology specialist and Maternal-Fetal Medicine Fellow at Stanford Medicine, expressed the need for such innovation: “Treatment for recurrent yeast infections has lagged, with no new therapeutic options for almost two decades. The current management strategies for recurrent yeast infections include long durations of fluconazole use, and although safe, compliance and patient satisfaction are not optimal.”

Understanding Chronic Yeast Infections

Chronic yeast infections, scientifically referred to as vaginal or vulvovaginal candidiasis, arise when the fungus Candida albicans disrupts the delicate balance of yeast and bacteria in the vaginal area. Symptoms often include vaginal itching, burning, inflammation, and irregular discharge. Pain during urination and sexual intercourse is also frequently reported.

Several factors can contribute to yeast infections, including a weakened immune system, pregnancy, recent antibiotic use, diabetes, or the use of oral contraceptives. Approximately 75% of individuals with internal genitals will experience at least one yeast infection in their lifetime, with 9% eventually developing RVVC. Traditionally, RVVC treatment has required prolonged use of both oral and topical antifungal drugs, with recurrence rates remaining high.

Dr. Miller noted the global treatment gap for individuals with recurrent yeast infections, citing the limitations of available topical antifungal and oral agents, including fluconazole. These treatments can be inconvenient for those with recurrent yeast infections, leading to low compliance and recurring symptoms.

The Mechanism Behind Vivjoa

The FDA’s approval of Vivjoa was based on three comprehensive clinical trials that assessed its effectiveness and safety in nearly 900 patients across more than 200 medical sites in 11 countries, including both global and U.S.-based studies. In these trials, 93% to 96% of participants, predominantly identified as women by drugmaker Mycovia, experienced no recurrence of RVVC during the 48-week trial period when using Vivjoa. In contrast, the placebo group reported recurrence rates of only 57% to 60%.

In the U.S.-based study, nearly 90% of RVVC patients treated with Vivjoa successfully cleared the infection, with no recurrence during the 50-week study period. This significantly outperformed the 57% recurrence rate among RVVC patients who received fluconazole followed by a placebo.

Vivjoa functions by inhibiting fungal growth and is designed for oral consumption. It can be used either independently or in combination with fluconazole. When used exclusively, Vivjoa is taken orally for two days, followed by once-weekly doses starting on day 14, spanning 11 weeks. If combined with fluconazole, fluconazole is taken on days one, four, and seven, with Vivjoa administered once daily for a week starting on day 14, followed by weekly doses for 11 weeks.

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

Who Should Avoid Vivjoa

Vivjoa is explicitly not intended for individuals who are pregnant, lactating, or capable of reproduction. This restriction stems from findings in animal studies suggesting the potential for Vivjoa to cause fetal harm. These studies, conducted on rats, revealed ocular abnormalities in offspring, including cataracts, opacities, hemorrhages, and optic nerve atrophy.

Dr. Terri Huynh, a gynecologic surgeon with Yale Medicine and assistant professor at Yale School of Medicine, highlighted the medication’s teratogenic nature, emphasizing its potential to induce birth defects. Consequently, Vivjoa should not be used by individuals who have the capacity to become pregnant, including those using contraception, as well as breastfeeding individuals. Due to its extended clearance time from the body, the drug is also deemed unsuitable for adolescents, as it has not been studied for safety in this age group.

Moreover, Vivjoa is contraindicated for individuals who exhibit allergies or sensitivities to oteseconazole or other components of the drug.

A Glimpse into the Future of Women’s Health

While Vivjoa is tailored to a specific subset of the female population, reproductive health specialists view its availability as a significant step forward in addressing a condition that affects numerous women. Dr. Huynh highlighted the importance of this development, particularly in an area of medicine that often receives inadequate attention and funding. She stated, “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. It is great to have additional tools to offer persons suffering from recurrent vaginitis symptoms.”

In conclusion, Vivjoa’s FDA approval represents a promising stride in the treatment of recurrent yeast infections, offering new hope for those who have long sought more effective solutions. While the drug is restricted to a specific demographic, its arrival is a testament to the ongoing efforts to enhance women’s healthcare and address medical needs that have remained unmet for far too long.