FDA Approves Osteseconazole for Recurrent Vulvovaginal Candidiasis

The FDA has approved osteseconazole (Vivjoa; Mycovia Pharmaceuticals) capsules for the treatment of recurrent vulvovaginal candidiasis (RVVC), also known as chronic yeast infection, in women with a history of the condition who are not of reproductive potential. The azole antifungal is the first and only FDA-approved treatment for RVVC, and showing sustained efficacy in significant long-term reduction of recurrence of the condition through 50 weeks compared with comparators, according to Mycovia Pharmaceuticals.

“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 clinical trial participant, in a press release. “It is gratifying to see RVVC finally get the attention it deserves.”

RVVC is defined by the CDC as 3 or more symptomatic acute episodes of yeast infection over 12 months. Approximately 75% of all adult women will have at least 1 yeast infection during their lifetime and approximately half will have a recurrence of the condition, with up to 9% developing RVVC, according to Mycovia Pharmaceuticals.

Symptoms of RVVC include vaginal itching, burning, irritation and inflammation. Some patients with the condition may experience abnormal vaginal discharge and painful sexual intercourse or urination, which can lead to variable but often severe discomfort and pain.

The approval of osteseconazole was based on findings from a trio of phase 3 trials—the 2 global, VIOLET studies and the US-focused ultraVIOLET study, which enrolled 875 patients across 11 countries.

In the VIOLET studies, 93.3% and 96.1% of patients with RVVC administered osteseconazole did not experience a recurrence for the 48-week maintenance period versus 57.2% and 60.6% of patients administered placebo (p <0.001).

In the ultraVIOLET study, 89.7% of women administered osteseconazole cleared an initial yeast infection and did not have a recurrence over the 50-week maintenance period versus 57.1% of patients administered fluconazole followed by placebo (p <0.001).

The most common adverse effects experienced with osteseconazole were headache (7.4%) and nausea (3.6%). The drug is contraindicated in patients with hypersensitivity to oteseconazole and in women who are of reproductive potential, pregnant, or lactating.

Mycovia announced plans for a commercial launch of osteseconazole in the second quarter of 2022.

“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has long been needed needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a press release. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”

Reference

FDA Approves Mycovia Pharmaceuticals’ VIVJOA™ (oteseconazole), the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection). Mycovia Pharmaceuticals. News release. April 28, 2022. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf