RVVC treatment drug oteseconazole now commercially available in US

Mycovia Pharmaceuticals recently announced US availability of oteseconazole (VIVJOA; Mycovia) for the treatment recurrent vulvovaginal candidiasis (RVVC) in women with a history of the chronic infection, who are postmenopausal and/or are without reproductive potential.¹

Oteseconazole—an azole antifungal agent—became the first and only RVVC treatment medication approved by the US Food and Drug Administration in April 2022. The drug’s 12-week treatment course provides women with long-term relief from RVVC for up to 1 year (50 weeks).

“Through our efforts, we will help patients understand that chronic yeast infection is a distinct condition from acute yeast infection,” said Tiffany Ahlers, chief commercial officer of Mycovia in a recent press release, “and VIVJOA was designed and studied in clinical trials to reduce the incidence of recurrent vaginal yeast infection in females with a history of RVVC.”1

A novel oral inhibitor of fungal CYP51, oteseconazole was studied in 3 clinical trials, including 2 global studies—VIOLET Trials 1 (NCT03562156) and 2 (NCT03561701)—and a US-based study, ultraVIOLET (NCT03840616). Although clinical efficacy data included women with reproductive potential, data showed oteseconazole to be contraindicated in pregnant and lactating women due to potential risks of embryonic and fetal toxicity. The most common side effects included headaches and nausea.

There are 2 treatment regimens for providers to consider when prescribing—oteseconazole on its own, or in combination with 150 mg of fluconazole.

For the oteseconazole-only regimen:

• Day 1: single dose of 600mg oteseconazole
• Day 2: single dose of 450mg oteseconazole
• Day 14: take 150mg oteseconazole once per week—every 7 days—for 11 weeks.

For the combination regimen:

• Day 1, Day 4, Day 7: single dose of 150mg fluconazole
• Days 14 to 20: 150mg oteseconazole once daily for 1 week
• Day 28: 150mg oteseconazole once per week—every 7 days—for 11 weeks.

As oteseconazole is a breast cancer resistance protein (BCRP) inhibitor, its use may increase the risk of adverse reactions when taken with certain breast cancer treatment drugs—specifically BCRP substrates such as rosuvastatin.

Oteseconazole is now available in a network of pharmacies and can be ordered by mail or picked up in-person, making treatment that much more accessible for women dealing with RVVC nationwide.

Reference

Mycovia Pharmaceuticals Announces U.S. Availability of VIVJOA (oteseconazole) Capsules, the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection). Businesswire.com. July 18, 2022. Accessed July 25, 2022. https://www.businesswire.com/news/home/20220718005049/en/Mycovia-Pharmaceuticals-Announces-U.S.-Availability-of-VIVJOA%E2%84%A2-oteseconazole-Capsules-the-First-and-Only-FDA-Approved-Medication-for-Recurrent-Vulvovaginal-Candidiasis-Chronic-Yeast-Infection