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Recently, Scinexis announced that its new broad-spectrum antifungal drug Brexafemme (ibrexafungerp, 150mg, tablets) has been launched in the United States.
Brexafemme was approved by the US FDA in early June 2021.
VVC is a disease that can affect up to three-quarters of women in their lifetime, but the treatment options are limited, with only one type of product (azoles) and one oral product (fluconazole), and no new ones have been approved for more than 20 years Product
Brexafemme is the first and only oral non-azole drug for the treatment of VVC.
In terms of medication, the recommended dose for adults and female adolescents after menarche is 300 mg (2 tablets of 150 mg), twice a day, with an interval of about 12 hours, for a total of 1 day.
ibrexafungerp chemical structure
Vulvovaginal candidiasis (VVC), commonly known as vaginal yeast infection caused by Candida, is the second most common cause of vaginitis
At present, the treatment of VVC includes several topical azole antifungals (clotrimazole, miconazole, etc.
The active pharmaceutical ingredient of Brexafemme is ibrexafungerp, which is a new, broad-spectrum antifungal drug and the first representative of triterpenoids, a glucan synthase inhibitor with a unique structure
VANISH clinical project efficacy data
The FDA approved Brexafemme based on data from the VANISH Phase 3 clinical project
The primary end point is the clinical cure at the TOC visit on day 10.
The results from the two studies both show that: Compared with placebo, Brexafemme has a high degree of statistical advantage in terms of primary endpoints and key secondary endpoints, and it is safe and well tolerated
——Results of the efficacy of the VANISH-306 study: On the 10th day of TOC visit, 63.
——Results of the efficacy of the VANISH-303 study: At the TOC visit on day 10, 50.
Note: The original text has been deleted
Original source: 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
