Oteseconazole (Vivjoa) was approved by the FDA to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
The Centers for Disease Control and Prevention defines RVVC as three or more symptomatic acute episodes of yeast infection in 12 months, a condition distinct from vulvovaginal candidiasis. Until now there have been no FDA-approved medications specifically indicated for RVVC.
The FDA’s approval of oteseconazole is based on positive results of three phase 3 trials of oteseconazole, two global, pivotal studies and one US-focused study, including 875 patients across 11 countries. In the two global studies, 93.3% and 96.1% of women with RVVC who received oteseconazole did not have a recurrence for the 48-week maintenance period, compared with 57.2% and 60.6% of patients who received placebo (P<.001). In the US study, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not have a recurrence for the 50-week maintenance period compared with 57.1% of those who received fluconazole followed by placebo (P<.001).
Based on animal studies, oteseconazole may cause fetal harm and is contraindicated in females of reproductive potential and in pregnant and lactating women because of potential risks to a fetus or breast-fed infant. The most common adverse effects reported in phase 3 clinical trials were headache and nausea.
Consult product labeling for important prescribing and safety information. Oteseconazole is a product of Mycovia Pharmaceuticals.
