Oteseconazole first FDA approved drug for recurrent vulvovaginal candidiasis
USA: The US Food and Drug Administration (FDA) has given approval to oteseconazole (Vivjoa), making it the first medication to be approved for chronic yeast infections treatment.
The oral drug however is indicated for recurrent vulvovaginal candidiasis (RVVC) only in women who are permanently infertile or postmenopausal due to embryo-fetal toxicity risks. In its press release, manufacturer Mycovia Pharmaceuticals noted that CDC defines RVVC as three or more symptomatic acute episodes of yeast infection within 12 months.
Oteseconazole is designed for inhibiting fungal CYP51 which is required for the integrity of fungal cell walls; this interaction is also toxic to fungi, leading to the inhibition of fungal growth.
The FDA approval was based on a trio of phase III trials -- two global trials (called VIOLET) and one in the U.S. (ultraVIOLET) -- comprising 875 patients across 11 countries.
Based on the trial, the researchers reported the following findings:
- 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.
