Drug updated on 4/18/2024
| 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.
Summary
- Oteseconazole (Vivjoa) is indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. The drug has demonstrated significant efficacy over both 24 and 48 weeks, proving its effectiveness in reducing the recurrence of RVVC.
- Two systematic review/meta-analysis studies provided valuable insights into Vivjoa's efficacy and safety profile, comparing it with existing and emerging antifungal agents for treating RVVC and multidrug-resistant Candida auris infections.
- Compared to Fluconazole, previously the standard treatment for RVVC, Oteseconazole offers a better safety profile and a lower recurrence rate, indicating its potential superiority for certain patient populations.
- Among investigational drugs targeting multidrug-resistant Candida auris, such as Ibrexafungerp, Rezafungin, and Manogepix/Fosmanogepix, Oteseconazole is notable for its inclusion among the promising tetrazole class agents.
- It is specified that Vivjoa is intended for use in females who have experienced previous episodes of RVVC but are not currently capable of reproduction, highlighting the specific patient group for which this drug is considered safe and effective.
- In conclusion, while further large-scale trials are recommended, particularly among a more varied patient population, the available data so far indicate that Oteseconazole shows promise in terms of safety and efficacy against traditional treatments like Fluconazole when addressing recurrent vulvovaginal candidiasis.
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 |