Brexafemme FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 22, 2022.
FDA Approved: Yes (First approved June 1, 2021)
Brand name: Brexafemme
Generic name: ibrexafungerp
Dosage form: Tablets
Company: Scynexis, Inc.
Treatment for: Vaginal Yeast Infection
Brexafemme (ibrexafungerp) is a first-in-class, triterpenoid antifungal agent used to treat vulvovaginal candidiasis (VVC), and to reduce the incidence of recurrent VVC in adults and adolescent females who have started their menstruation.
- Vulvovaginal candidiasis (vaginal yeast infection due to Candida) is frequently caused by Candida albicans, although infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be increasing.
- Brexafemme works as an antifungal against the Candida species by inhibiting glucan synthase, an enzyme involved in the formation of an essential component of the fungal cell wall.
- For the treatment of vulvovaginal candidiasis, Brexafemme tablets are administered orally in two doses, approximately 12 hours apart. For recurrent vulvovaginal candidiasis, two doses are administered approximately 12 hours apart, every month for six months.
- Brexafemme carries a Boxed Warning for the risk of embryo-fetal toxicity. Brexafemme is contraindicated in pregnancy and females of reproductive potential are advised to use effective contraception during treatment.
- Common adverse reactions reported in patients using Brexafemme for the treatment of VVC include diarrhea, nausea, abdominal pain, dizziness, and vomiting.
Common adverse reactions reported in patients using Brexafemme for the reduction in the incidence of recurrent VVC include headache, abdominal pain, diarrhea, nausea, urinary tract infection, and fatigue.
Development timeline for Brexafemme
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
