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Looking at the first FDA-approved medication for RVVC

Jack D. Sobel, MD, examines the efficacy and safety of oteseconazole in reducing the incidence of recurrent vulvovaginal candidiasis in patients.

At the 2022 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting in San Diego, California, Jack Sobel, MD, Dean and Distinguished Professor at Wayne State University School of Medicine in Detroit, Michigan, discussed how the condition of recurrent vulvovaginal candidiasis (RVVC), a chronic version of vulvovaginal candidiasis (VVC) affects women; past treatments; and the newly-approved FDA drug, oteseconazole (Vivjoa).

According to the US Centers for Disease Control and Prevention, RVVC is defined as 3 or more symptomatic, acute episodes of yeast infection in a year, affecting up to 9% of women in the United States, with nearly half of women with RVVC aged 45 and older. The condition makes a significant impact on quality of life, including a burden on their mental health, expressing through depression and anxiety. Up until now, current treatment protocols included both prescription and topical OTC azole antifungals (fluconazole, which emerged in 2004) not approved by the FDA. While fluconazole did alleviate symptoms of RVVC, it could not combat recurrence rates.

A new treatment option has emerged. Oteseconazole (Vivjoa), approved by the FDA in April 2022, has been shown to reduce the incidence of RVVC in older women (those who are not of reproductive age). For ob gyns, this is important to note to their patients who are of reproductive age, as oteseconazole can cause fetal harm (ocular toxicities). Oteseconazole has been proven effective against several different candida organisms, including candida albicans, candida glabrata, candida tropicalis, and others. It works by inhibiting fungal CYP51, the element required for fungal wall integrity. It is both more than 2000 times more selective than fluconazole for fungal CYP51 and offers a lower affinity for host theme-iron than other azoles.

Trials to test the safety of oteseconazole and its ability to prevent recurring episodes of RVVC showed an overwhelming majority (roughly 95%) of women receiving oteseconazole did not have a recurrence for almost a year (compared with approximately 60% of patients receiving the placebo.) Additionally, investigators noted, otesconazole was safe and well-tolerated with no notable differences in adverse events between osteseconazole and placebo groups.

Reference

Sobel J. Introducing the first and only medication approved by the FDA to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC). Presented at: 2022 American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting. May 6, 2022. San Diego, California.