Oteseconazole Becomes First FDA-Approved Medication for Chronic Yeast Infection

Article

The azole antifungal treatment was approved by the FDA to reduce the incidence of recurrent vulvovaginal candidiasis, or chronic yeast infection.

Oteseconazole Becomes First FDA-Approved Medication for Chronic Yeast Infection

The US Food and Drug Administration (FDA) approved osteseconazole (Vivjoa) capsules, an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC), also referred to as chronic yeast infection. Included in the indication are women with a history of the condition who are not of reproductive potential.

The antifungal is the first and only FDA-approved medication for chronic yeast infection. It's also the first FDA-approved product to come from Mycovia Pharmaceuticals, a biopharmaceutical company dedicated developing novel therapies to empower people living with unmet medical needs.

About 75% of adult women will experience at least one yeast infection in their lifetime, and about half of that population experiences a recurrence. Up 9% of those women develop RVVC.

Reducing Chronic Yeast Infections

Sustained efficacy of osteseconazole was exhibited by significant long-term reduction of RVVC recurrence over 50 weeks. The approval is based on data from 3 phase 3 trials, pivotal VIOLET studies and a US-focused ultraVIOLET study.

The Centers for Disease Control and Prevention (CDC) define RVVC as 3 or more symptomatic acute episodes of yeast infection within a year and is a distinct condition from vulvovaginal candidiasis (VVC). Women with RVVC experience symptoms like vaginal itching, burning, irritation and inflammation. Additionally, some are affected by severe pain as a result of abnormal vaginal discharge, painful sexual intercourse, or painful urination.

“A medicine with VIVJOA’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, Chief Development Officer, Mycovia, said in a statement. “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.”

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