The US FDA has approved oteseconazole capsules as the first drug for women with recurrent vulvovaginal candidiasis. However, the FDA has cautioned that the drug is to be used only in women who are not of reproductive potential i.e., postmenopausal and permanently infertile, due to the risk of embryo-fetal toxicity. It has been approved as 150 mg capsules.

Dosage and administration: 600 mg (single dose) on the first day; 450 mg single dose on the second day and once weekly for 11 weeks starting from the 14^th day. It is to be taken with food.

Oteseconazole can also be coadministered with fluconazole prescribed as fluconazole 150 mg orally on Day 1, 4 and 7 followed by oteseconazole 150 mg once daily for 7 days. Starting from the 28^th day, oteseconazole is given once weekly for 11 weeks.

Adverse effects: Headache, nausea

Contraindications: Hypersensitivity to oteseconazole, pregnant or lactating women or women with reproductive potential.

Oteseconazole is not recommended for use in women with severe renal impairment or end-stage renal disease, or those with moderate or severe hepatic impairment.

Oteseconazole is an anti-azole antifungal. The approval for the drug is based on the results of three phase III trials: VIOLET (two international trials) and ultraVIOLET conducted in the US. The drug will be launched in the second quarter of 2022.

(Source: US FDA & Medscape, April 28, 2022)