FDA Approves Osteseconazole for Recurrent Vulvovaginal Candidiasis

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Osteseconazole (Vivjoa) is the first FDA-approved treatment for recurrent vulvovaginal candidiasis, also known as chronic yeast infection, in women with a history of the condition who have no reproductive potential.

The FDA has approved osteoconazole (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 shows sustained efficacy in significantly reducing disease recurrence over 50 weeks long-term compared to comparators, according to Mycovia Pharmaceuticals.

“After living with a chronic yeast infection for almost two decades and feeling like there was no hope left due to the itching, irritation and constant fear of when the next yeast infection would come back, I was overjoyed at even being on this clinical one study,” said Leslie Ivey, RVVC patient and clinical trial participant, in a press release. “It’s gratifying to see that RVVC is finally getting the attention it deserves.”

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

Symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients with this condition may experience abnormal vaginal discharge and painful intercourse or urination, which can cause varying but often severe discomfort and pain.

The approval of osteoconazole was based on the results of a trio of Phase 3 studies – the 2 global VIOLET studies and the US-focused ultraVIOLET study, which enrolled 875 patients in 11 countries.

In the VIOLET studies, 93.3% and 96.1% of patients with RVVC receiving osteoconazole had no recurrence during the 48-week maintenance period compared to 57.2% and 60.6% of patients who received osteoconazole. who received placebo (p

In the ultraVIOLET study, 89.7% of women given osteoconazole cleared an initial yeast infection and had no recurrence during the 50-week maintenance period compared to 57.1% of patients given fluconazole followed by placebo ( p

The most common side effects of osteoconazole were headache (7.4%) and nausea (3.6%). The drug is contraindicated in patients with hypersensitivity to oteseconazole and in women of childbearing potential, pregnant or lactating.

Mycovia announced plans to commercialize osteoconazole in Q2 2022.

“A drug with Vivjoa’s continued efficacy combined with its clinical safety profile has been needed for a long time because physicians and their patients have not had FDA-approved drugs for RVVC to date,” said Stephen Brand, PhD, Mycovia’s chief development officer in a press release. “We are excited to be the first to offer a drug designed specifically for RVVC, a challenging and chronic condition whose prevalence is expected to increase over the next decade.”

reference

FDA Approves Mycovia Pharmaceuticals’ VIVJOA™ (oteseconazole), the first and only FDA-approved drug for recurrent vulvovaginal candidiasis (chronic yeast infection). Mycovia Pharmaceuticals. press release. April 28, 2022. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf

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