Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 150 mg) |
| Drug Class | Triterpenoid antifungals |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).
Summary
- Ibrexafungerp (Brexafemme) is a novel antifungal treatment used for the management of vulvovaginal candidiasis (VVC) in adult and post-menarchal pediatric females.
- Three randomized controlled trials were reviewed to gather information about this drug's effectiveness and safety profile.
- The pooled data from two phase three studies, VANISH 303 and 306, showed that patients receiving ibrexafungerp had significantly higher rates of clinical cure, clinical improvement, and mycological cure compared to those who received placebo at the test-of-cure visit on day 11±3.
- At the follow-up visit on day 25±4 after treatment with ibrexafungerp, sustained responses with higher symptom resolution rates were observed as compared to placebo-treated patients.
- Subgroup analysis revealed that race, body mass index (BMI), baseline vulvovaginal signs and symptoms score or Candida species infection did not adversely affect clinical cure rates when treated with ibrexafungerp; indicating its broad-spectrum efficacy across diverse patient populations.
- Safety analysis results indicated that ibrexafungerp was generally well tolerated by patients; adverse events reported were primarily gastrointestinal in nature but mild to moderate in severity which suggests it has an acceptable safety profile for treating acute VVC cases effectively within one day of oral administration.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Brexafemme (ibrexafungerp tablets) Prescribing Information. | 2022 | SCYNEXIS Inc., Jersey City, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Oral ibrexafungerp for vulvovaginal candidiasis treatment: an analysis of vanish 303 and VANISH 306. | 820Subjects F: 100% M: 0% | 2023 | Journal of Women’s Health |
| Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a phase 3, randomized, controlled superiority trial (VANISH 303). | 376Subjects F: 100% M: 0% | 2021 | Clinical Infectious Diseases |
| Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a global phase 3, randomised, placebo-controlled superiority study (VANISH 306). | 455Subjects F: 100% M: 0% | 2021 | BJOG: An International Journal of Obstetrics and Gynaecology |
Document Title
Sex Distribution:
F:100%
M:0%
820Subjects
Year:
2023
Source:Journal of Women’s Health
Sex Distribution:
F:100%
M:0%
376Subjects
Year:
2021
Source:Clinical Infectious Diseases
Sex Distribution:
F:100%
M:0%
455Subjects
Year:
2021
Source:BJOG: An International Journal of Obstetrics and Gynaecology