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The FDA gave the green light to oteseconazole (Vivjoa), making it the first approved medication to treat chronic yeast infections, manufacturer on Thursday.

Due to embryo-fetal toxicity risks, however, the oral drug is indicated for recurrent vulvovaginal candidiasis (RVVC) only in women who are permanently infertile or postmenopausal. In its press release, Mycovia noted that the CDC defines RVVC as three or more symptomatic acute episodes of yeast infection within 12 months.

Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity; this interaction is also toxic to fungi, leading to the inhibition of fungal growth.

Approval was based on a trio of phase III trials -- two global trials (called VIOLET) and one in the U.S. () -- comprising 875 patients across 11 countries.

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%; P<0.001 for both). 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 (P<0.001).

The most frequently reported adverse events were headache (7.4% of patients) and nausea (3.6%).

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.

A commercial launch of the drug is planned for the second quarter of 2022, Mycovia noted.

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