Drug updated on 11/5/2024
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
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Oteseconazole significantly reduced the incidence of recurrent vulvovaginal candidiasis (RVVC) through week 48, with an odds ratio (OR) of 0.07 (95% Confidence Interval (CI): 0.05–0.11, p < 0.00001).
- The incidence of RVVC was also significantly reduced by Oteseconazole through week 24, with an OR of 0.05 (95% CI: 0.03–0.09, p < 0.00001).
- No specific population or subgroup findings were provided regarding differences in effectiveness.
- Oteseconazole was non-significantly associated with developing serious adverse effects compared to placebo, with an Odds Ratio of 0.79 (95% CI: 0.33-1.89, p=0.60).
- There were no significant safety concerns or adverse effects identified for Oteseconazole in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vivjoa (oteseconazole) Prescribing Information. | 2024 | 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 |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Treatment of Vulvovaginal Candidiasis-An Overview of Guidelines and the Latest Treatment Methods. | 2023 | Journal of Clinical Medicine |