Brexafemme® (ibrexafungerp tablets) is now available for the treatment of vulvovaginal candidiasis in adult and postmenarchal pediatric females.
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids. It has been shown to have broad spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.
The approval of Brexafemme was based on data from the multicenter, randomized, double-blind, placebo-controlled phase 3 VANISH-303 (ClinicalTrials.gov Identifier: NCT03734991) and VANISH-306 (ClinicalTrials.gov Identifier: NCT03987620) trials, which compared the efficacy and safety of ibrexafungerp to placebo in female patients aged 12 years and older with acute vulvovaginal candidiasis.
Findings from both studies showed that a greater proportion of patients treated with Brexafemme met the primary endpoint of clinical cure, defined as complete resolution (score of 0) of all signs and symptoms at the test-of-cure visit on day 10, compared with placebo. Moreover, mycological eradication at test-of-cure and complete clinical response at follow-up were significantly higher in patients treated with Brexafemme compared with placebo.
As for safety, the most common adverse reactions associated with Brexafemme treatment were diarrhea, nausea, abdominal pain, dizziness, and vomiting.
Prior to initiating treatment, pregnancy status in females of reproductive potential should be verified as pregnancy is a contraindication. Dosage modification is warranted for patients taking concomitant strong CYP3A inhibitors; concomitant administration of strong and moderate CYP3A inducers should be avoided.
Brexafemme is supplied as 150mg tablets in 4-count blister packs.
- Scynexis announces US availability of Brexafemme (ibrexafungerp tablets), the first new antifungal class of therapy approved by the US FDA for vaginal yeast infections in more than 20 years. News release. Scynexis. Accessed September 22, 2021. https://www.globenewswire.com/news-release/2021/09/22/2301313/0/en/SCYNEXIS-Announces-U-S-Availability-of-BREXAFEMME-ibrexafungerp-tablets-the-First-New-Antifungal-Class-of-Therapy-Approved-by-the-U-S-FDA-for-Vaginal-Yeast-Infections-in-More-Than-.html.
- Brexafemme. Package insert. Scynexis; 2021. Accessed September 22, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214900s000lbl.pdf.