Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 150 mg) |
Drug Class | Triterpenoid antifungals |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and post-menarchal pediatric females for vulvovaginal candidiasis (VVC).
- Indicated for the treatment of adult and post-menarchal pediatric females for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
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Summary
- Brexafemme (ibrexafungerp) is indicated for the treatment of adult and post-menarchal pediatric females for vulvovaginal candidiasis (VVC) and for reducing the incidence of recurrent vulvovaginal candidiasis (RVVC).
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Clinical Cure Rate: Ibrexafungerp demonstrated a superior clinical cure rate with a risk ratio (RR) of 1.33 (95% CI: 1.07, 1.66) compared to fluconazole/placebo in the treatment of vulvovaginal candidiasis (VVC). However, in a phase 2 study, ibrexafungerp showed similar efficacy to fluconazole (51.9% vs. 58.3% clinical cure rates). Two phase 3 trials confirmed ibrexafungerp's superiority over placebo in moderate to severe VVC (P < 0.001 and P = 0.023).
- Mycological Eradication Rate: Ibrexafungerp exhibited a superior mycological eradication rate with an RR of 1.72 (95% CI: 1.00, 2.95) when compared to fluconazole/placebo.
- Overall Success Ratio: Ibrexafungerp showed a higher overall success ratio with an RR of 1.64 (95% CI: 0.92, 2.92) relative to fluconazole/placebo.
- The duration of treatment-related treatment-emergent adverse events (TEAE), including nausea and diarrhea, was significantly longer for patients treated with ibrexafungerp compared to fluconazole/placebo.
- Gastrointestinal-related symptoms were the most frequently reported adverse reactions in clinical trials for ibrexafungerp.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Brexafemme (ibrexafungerp tablets) Prescribing Information. | 2022 | SCYNEXIS Inc., Jersey City, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of ibrexafungerp in the treatment of vulvovaginal candidiasis: a meta-analysis of randomized controlled trials. | 2024 | Heliyon |
Ibrexafungerp in the treatment of vulvovaginal candidiasis. | 2023 | The Annals of Pharmacotherapy |
Recent antifungal pipeline developments against candida auris: a systematic review. | 2022 | Journal of Fungi |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Vulvovaginal candidiasis: a review of the evidence for the 2021 centers for disease control and prevention of sexually transmitted infections treatment guidelines. | 2022 | Clinical Infectious Diseases |