OTE-DT-QA-001 PLS 20 June.pdf (215.6 kB)

Oteseconazole in recurrent vulvovaginal candidiasis: a profile of its use

online resource

posted on 2023-06-27, 22:53 authored by Simon Fung, Matt Shirley

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and conflict of interest 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.

Additional information about this Adis Drug Review can be found here.

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.