Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 150 mg) |
Drug Class | Azole antifungals |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.
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Summary
- Vivjoa (oteseconazole) is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Recurrent Vulvovaginal Candidiasis (RVVC) Treatment: Oteseconazole (Vivjoa) significantly reduced the incidence of RVVC, with a pooled odds ratio (OR) of 0.07 (95% CI = 0.05-0.11) through week 48 and an OR of 0.05 (95% CI = 0.03-0.09) through week 24.
- Multidrug-Resistant Candida auris (C. auris) Infections: Oteseconazole, alongside other investigational antifungals, showed significant improvements in survival and reductions in tissue fungal burden in neutropenic animal models of candidemia due to C. auris.
- Oteseconazole was non-significantly associated with developing serious adverse effects during the treatment for recurrent vulvovaginal candidiasis (RVVC) compared to placebo (OR = 0.79; 95% CI = 0.33-1.89; p = 0.60, I² = 0%).
- Safety outcomes for Oteseconazole in the context of Candida auris infections were not explicitly discussed.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vivjoa (oteseconazole) prescribing information. | 2022 | Mycovia Pharmaceuticals, Inc. Durham, NC |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
"Efficacy and safety of oteseconazole in recurrent vulvovaginal candidiasis (RVVC) - a systematic review and meta-analysis." | 2023 | Heliyon |
Recent antifungal pipeline developments against candida auris: a systematic review. | 2023 | Journal of Fungi |