Currently Enrolling Trials
Brexafemme (ibrexafungerp) is a triterpenoid antifungal.
Brexafemme is specifically indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis.
Brexafemme is supplied as tablets for oral administration. The recommended dose is 300 mg (two 150 mg tablets) administered approximately 12 hours apart (e.g., in the morning and in the evening) for one day, for a total daily dosage of 600 mg (four 150 mg tablets). Brexafemme may be taken with or without food.
Mechanism of Action
Brexafemme (ibrexafungerp) is a triterpenoid antifungal drug. Ibrexafungerp inhibits glucan synthase, an enzyme involved in the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall. Ibrexafungerp has concentration-dependent fungicidal activity against Candida species as measured by time kill studies. Ibrexafungerp retains in vitro antifungal activity when tested at pH 4.5 (the normal vaginal pH).
Adverse effects associated with the use of Brexafemme may include, but are not limited to, the following:
- abdominal pain
The FDA approval of Brexafemme was based on two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306). The trials were designed to evaluate the safety and efficacy of a single day of Brexafemme 600 mg (two 150 mg tablets per dose, administered 12 hours apart) for the treatment of VVC. The primary endpoint required for registration is clinical cure, defined as complete resolution (score of 0) of all signs and symptoms at the Day-10 test-of-cure (TOC) visit. In VANISH-303 the observed clinical cure for ibrexafungerp was 50.5%, showing highly statistically significant superiority to placebo. In VANISH-306, 63.3% of ibrexafungerp-treated patients met the primary endpoint of clinical cure at the Day-10 TOC visit.