Ibrexafungerp

(Brexafemme®)

Brexafemme®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 150 mg)
Drug ClassTriterpenoid 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
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  • 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.