Oteseconazole first FDA approved drug for recurrent vulvovaginal candidiasis

• In the VIOLET studies, a significantly higher proportion of women randomized to receive the intervention reported no RVVC recurrence during the 48-week maintenance period versus those who received placebo (93.3% vs 57.2% and 96.1% vs 60.6%).
• In the ultraVIOLET study, 89.7% of women who received oteseconazole cleared their initial yeast infection and experienced no recurrence over a 50-week maintenance period compared with 57.1% of women who received fluconazole followed by placebo.
• The most frequently reported adverse events were headache (7.4% of patients) and nausea (3.6%).

"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. "It is gratifying to see RVVC finally get the attention it deserves." 

According to the FDA label, oteseconazole should be taken with food, and administered on day 1 at 600 mg, day 2 at 450 mg, and then at 150 mg once a week for 11 weeks starting on day 14. It can also be co-administered with fluconazole, with different dosing instructions. 

The drug is contraindicated for pregnant and lactating women and those with hypersensitivity to the drug. Based on animal studies, it may cause fetal harm. The drug is not recommended for women with severe renal impairment or end-stage renal disease, or those with moderate or severe hepatic impairment. Certain breast cancer drugs may also interfere with oteseconazole.