FDA Approves First Drug for Recurrent Vulvovaginal Candidiasis

The FDA recently approved the first drug for recurrent vulvovaginal candidiasis (RVVC), or chronic yeast infection. The drug, oteseconazole, is an azole antifungal indicated to reduce the incidence of RVVC in females with a history of RVVC who are infertile or postmenopausal.

RVVC is defined by the CDC as 3 or more symptomatic acute episodes of yeast infection in 12 months. RVVC is a distinct condition from vulvovaginal candidiasis (VVC). Nearly 75% of all adult women will have at least 1 yeast infection in their lifetime. About half will see a recurrence, and of those women, up to 9% develop RVVC.

The approval is based upon the positive results from 3 phase 3 trials of oteseconazole, said Mycovia Pharmaceuticals, which received the approval.

The 2 global VIOLET studies and 1 US-focused study included 875 patients at 232 sites in 11 countries.

In the global studies, 93.3% and 96.1% of women with RVVC who received oteseconazole did not have a recurrence in the 48-week maintenance period. This is compared with those who received placebo, among whom 57.2% and 60.6% did not experience recurrence.

In the US study, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and had no recurrent infections for the 50-week maintenance period, while 57.1% of women who received fluconazole and placebo had no recurrence. The most frequently reported adverse events were headache and nausea, occurring in 7.4% and 3.6% of trial participants, respectively.

Animal studies suggest the drug may cause fetal harm, which is why the therapy is contraindicated for women of childbearing age, as well as women who are currently pregnant or breastfeeding. Based on the half-life of oteseconazole, the drug’s exposure window of 690 days carries embryo-fetal toxicity risks.

The drug is also contraindicated in those with a hypersensitivity to oteseconazole.

Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selective interaction is also toxic to fungi, resulting in the inhibition of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared with fungal CYP enzymes.

RVVC is a debilitating, chronic infectious condition that affects 138 million women worldwide each year. Symptoms of RVVC include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain, according to the company.

The FDA granted oteseconazole Qualified Infectious Disease Product and Fast Track designations.

The drug will be sold under the name Vivjoa and is expected to launch in the second quarter.