FDA Approves Oteseconazole, First and Only Treatment for Chronic Yeast Infection

Today, the FDA approved oteseconazole to treat recurrent vulvovaginal candidiasis (RVVC). Marketed under the name Vivjoa, the drug is the first FDA approval for manufacturer Mycovia Pharmaceuticals.

Today, the US Food and Drug Administration (FDA) approved oteseconazole (marketed under the name Vivjoa), the first and only medication authorized for chronic yeast infection.

Vivjoa, oteseconazole capsules, reduces the incidence of recurrent vulvovaginal candidiasis (RVVC) in women with a history of RVVC who are not planning to get pregnant. Oteseconazole was previously granted Fast-Track and Qualified Infectious Disease Product designations by the FDA.

Vivjoa was developed by Mycovia Pharmaceuticals, Inc., and marks the first FDA approval for the biopharmaceutical company. Mycovia states that they are devoted to “recognizing and empowering” persons with unmet medical needs through their novel therapies.

The FDA approved Vivjoa after reviewing positive results from 3 different phase 3 clinical trials of oteseconazole. The 2 global VIOLET studies and 1 US-focused ultraviolet 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 to the placebo recipients, among whom 57.2% and 60.6% did not experience recurrence.

In the ultraviolet study, 89.7% of women with RVVC who received oteseconazole cleared their initial yest infection and had no recurrent infections for the 50-week maintenance period. 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.

RVVC, commonly called chronic yeast infection, is defined as 3 or more symptomatic acute episodes of yeast infection in the span of 12 months. Almost 75% of adult women will have at least 1 yeast infection in their lives, and approximately 50% of them will experience recurrence. Of these women, up to 90% develop RVVC.

Until now, there was no FDA-approved treatment specifically indicated for RVVC. Symptoms include vaginal itching, burning, irritation, and inflammation. Some women experience abnormal vaginal discharge and painful urination or sexual intercourse.

“After nearly two decades of living with chronic yeast infection and feeling like there was no hope from the itchiness, irritation and constant dread of when the next yeast infection would return, I was overjoyed to even be a part of this clinical trial,” said Leslie Ivey, RVVC patient and a participant in the oteseconazole clinical trial. “It is gratifying to see RVVC finally get the attention it deserves.”

The azole antifungal was proven to significantly reduce long-term RVVC through 50 weeks, as compared to other agents. Oteseconazole inhibits fungal CYP51, which is required for fungal cell wall integrity. Oteseconazole’s selective interaction is also toxic to fungi, preventing its growth.

Animal studies suggest Vivjoa may cause fetal harm, which is why the therapy is contraindicated for women of reproductive potential, 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.

Mycovia emphasized the potential of oteseconazole as an oral fungal inhibitor, hoping the therapy can be expanded to treat other multidrug-resistant fungal pathogens. “We believe the market need for Vivjoa is strong, and we are eager to execute our commercial plans,” said Patrick Jordan, the CEO of Mycovia Pharmaceuticals and a partner at NovaQuest Capital Management. “As we enter a new chapter of our history as a commercial biopharmaceutical company, we will continue driving our mission forward to develop novel therapies for overlooked conditions.”