Brexafemme (ibrexafungerp) - 2 indications

Scroll down for more information on each indication:

• for the treatment of vulvovaginal candidiasis (VVC); approved June of 2021
• for a reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC); approved December of 2022

General Information

Brexafemme (ibrexafungerp) is a triterpenoid antifungal.

Brexafemme is specifically indicated for:

• the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis;
• a reduction in the incidence of recurrent vulvovaginal candidiasis.

Brexafemme is supplied as tablets for oral administration. Scroll down for dosing/administration for each indication.

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).

Side Effects

Adverse effects associated with the use of Brexafemme for the treatment of VVC may include, but are not limited to, the following: 

• diarrhea
• nausea
• abdominal pain
• dizziness
• vomiting 

Adverse effects associated with the use of Brexafemme for reduction in the incidence of RVVC may include, but are not limited to, the following: 

• headache
• abdominal pain
• diarrhea
• nausea
• urinary tract infection
• fatigue

The Brexafemme drug label comes with the following Black Box Warning:

Brexafemme  is contraindicated in pregnancy because it may cause fetal harm based on findings from animal reproductive studies.  For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. Reassessing pregnancy status prior to each dose is recommended when Brexafemme  is used monthly for 6 months for reduction in the incidence of RVVC. Advise females of reproductive potential to use effective contraception during treatment of VVC and throughout the 6-month treatment period for reduction in the incidence of RVVC with Brexafemme  and for 4 days after the last dose.

Indication 1 - the treatment of vulvovaginal candidiasis

approved June of 2021

Dosing/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.

Clinical Trial Results

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.

Indication 2 -  for a reduction in the incidence of recurrent vulvovaginal candidiasis

approved December of 2022

Dosing/Administration

The recommended dosage in adult and post-menarchal females is 300 mg (two tablets of 150 mg) 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) monthly for six months. Brexafemme may be taken with or without food.

Clinical Trial Results

The FDA approval of Brexafemme for RVVC was based on the pivotal Phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of ibrexafungerp to reduce the incidence of RVVC. Results showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed, or suspected, through Week 24 compared to 53.1% of placebo-treated patients. The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant.