Oteseconazole: An Advance in Treatment of Recurrent Vulvovaginal Candidiasis

Abstract

Recurrent vulvovaginal candidiasis (RVVC) has significant disease, financial and quality-of-life burdens, affects women from all strata of society worldwide, and lacks an approved therapeutic solution. Fluconazole emerged in 2004 as an antifungal for RVVC; it provides symptom control and has been accepted worldwide as a first-line treatment. Its limitations include the development of resistance and a high rate of vulvovaginal candidiasis recurrence after therapy cessation. There is now an improved treatment option on the horizon: oteseconazole – a novel, oral, selective fungal cytochrome P450 enzyme 51 inhibitor, designed to avoid off-target toxicities. In clinical studies to date, oteseconazole has demonstrated impressive efficacy, a positive tolerability profile and hope for a superior RVVC treatment option.

Lay abstract

Many women are affected by vaginal fungal infections, also called yeast infections. These infections can affect normal daily activities and have negative emotional and financial effects as well, especially for women who have yeast infections repeatedly. There is no US FDA-approved treatment for repeated yeast infections although the symptoms are often managed with a prescription antifungal medication, fluconazole. However, using fluconazole can have health risks, especially when it is used repeatedly over months or years. Another problem is that the yeasts that cause the infection can become resistant to the treatment. A new medication has been developed and tested in clinical studies and may soon provide women with an effective treatment option for repeated yeast infections that is also safer.

Infographic

Infographic: A PDF version of this infographic is available as supplemental material.

Keywords::

• antifungal
• Candida
• CYP51
• fungal lanosterol demethylase
• oteseconazole
• recurrent vulvovaginal candidiasis
• vaginitis
• VT-1161
• vulvovaginal candidosis

Supplementary data

Acknowledgments

Susan A Leon and Tam Minh Nguyen-Cao of Claritas Scientific LLC provided medical writing services under the direction of the authors, and Ann D Bledsoe Bollert of Y-Axis Editorial provided editorial expertise.

Financial & competing interests disclosure

Oteseconazole is under development by Mycovia Pharmaceuticals Inc. (Mycovia) for the treatment of recurrent vulvovaginal candidiasis. Mycovia was not involved in the development of this article. The authors worked independently from Mycovia. Jack D Sobel participated as a principal investigator of the Phase III VIOLET studies (NCT03562156 and NCT03561701) and has also served as a consultant for and/or has received research funding from Mycovia Pharmaceuticals and Scynexis. Paul Nyirjesy participated as a principal investigator of the VIOLET Study and has also served as a consultant for and/or has received research funding from Mycovia Pharmaceuticals, Scynexis Inc., and Hologic Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing services for this article were sponsored by Mycovia Pharmaceuticals Inc.

Additional information

Funding

Oteseconazole is under development by Mycovia Pharmaceuticals Inc. (Mycovia) for the treatment of recurrent vulvovaginal candidiasis. Mycovia was not involved in the development of this article. The authors worked independently from Mycovia. Jack D Sobel participated as a principal investigator of the Phase III VIOLET studies (NCT03562156 and NCT03561701) and has also served as a consultant for and/or has received research funding from Mycovia Pharmaceuticals and Scynexis. Paul Nyirjesy participated as a principal investigator of the VIOLET Study and has also served as a consultant for and/or has received research funding from Mycovia Pharmaceuticals, Scynexis Inc., and Hologic Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.