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Oteseconazole in recurrent vulvovaginal candidiasis: a profile of its use

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Abstract

Oteseconazole (Vivjoa®), an orally administered azole antifungal, is a valuable, efficacious, and well tolerated treatment option for reducing the incidence of vulvovaginal candidiasis (VVC) recurrence in females with a history of recurrent VVC (RVVC) who are not of reproductive potential. It is the first drug to be approved in the USA for this indication. In phase 3 clinical trials in patients with RVVC, oteseconazole significantly reduced the incidence of VVC recurrence compared with placebo and continued to prevent VVC recurrence for over 36 weeks after the final dose of the drug. Oteseconazole was non-inferior to fluconazole for resolving acute VVC. Additionally, it has a favorable pharmacokinetic profile, has activity against fluconazole-resistant Candida strains, and is generally well tolerated in patients with RVVC.

Plain Language Summary

Recurrent vulvovaginal candidiasis (RVVC), commonly known as chronic vaginal yeast infection, causes physical discomfort and psychological distress. Current recommended treatments for RVVC, including azole antifungals (e.g., fluconazole), fail to prevent recurrence in about half of patients. Oteseconazole (Vivjoa®) is the first drug to gain approval for the treatment of RVVC in the USA after it significantly reduced the incidence of vulvovaginal candidiasis (VVC) recurrence in patients compared with placebo in pivotal phase 3 trials. Oteseconazole reduces recurrence for over 36 weeks after the final dose of the drug, has activity against Candida strains that are resistant to azole antifungals, and is generally well tolerated. Thus, oteseconazole is a valuable addition to the drugs available to treat RVVC.

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Acknowledgements

The manuscript was reviewed by: A. Dovnik, University Clinic for Gynecology and Obstetrics, Maribor University Medical Centre, Maribor, Slovenia; S. Mahmoudi, Department of Parasitology and Mycology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran; J. Rolo, CICS-UBI–Health Sciences Research Centre, Universidade da Beira Interior, Covilhã, Portugal; F. Wirth, Department of Microbiology, University of São Paulo, São Paulo, Brazil. During the peer review process, Mycovia Pharmaceuticals Inc., the marketing authorization holder of oteseconazole, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Simon Fung & Matt Shirley

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Correspondence to Simon Fung.

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S. Fung and M. Shirley are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Fung, S., Shirley, M. Oteseconazole in recurrent vulvovaginal candidiasis: a profile of its use. Drugs Ther Perspect 39, 263–269 (2023). https://doi.org/10.1007/s40267-023-01008-x

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