Scynexis announces FDA approval of Brexafemme as the first and only oral non-azole treatment for vaginal yeast infections
Scynexis Inc.,. announced that the FDA has approved Brexafemme(ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Brexafemme which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase III studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.
Scynexis has partnered with Amplity Health, a leading global contract commercialization organization, to support U.S. commercialization of Brexafemme with commercial launch scheduled in the second half of this year.