The newly approved therapy will use the brand name, Brexafemme, and is a one-day, novel, oral treatment for vaginal yeast infection.
Scynexis announced it will commercially launch its Brexafemme (ibrexafungerp) therapy in the 3rd quarter of 2021 at a media event today. The company plans a full marketing rollout for its launch in the coming months.
During her presentation at the event, Scynexis Chief Commercial Officer Christine Coyne said she expects the product to be available and on shelves in early August.
Coyne said 84% of healthcare providers (HCP) surveyed would provide Brexafemme upon patient request and that HCPs would consider it as a first-line therapy.
Earlier this month, the Food and Drug Administration (FDA) approved ibrexafungerp for treatment of vulvovaginal candidiasis (VVC).
“The FDA approval of Brexafemme is the culmination of years of work and a significant milestone for Scynexis, marking our evolution to a commercial-stage antifungal company. We are pleased with the approved label, highlighting the unique attributes of Brexafemme, and thrilled to be able to offer a new treatment option to women with vaginal yeast infections,” Scynexis CEO Marco Taglietti, MD, said at the time of the approval.
The therapy, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from 2 phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. Data from their phase 3 VANISH program, which had its VANISH 306 AND VANISH 303 studies, showed ibrexafungerp met its endpoints and achieved statistically significant superiority vs. placebo. In its VANISH 306 study, 188 participants were in the treatment arm and 84 were placed in the placebo group. In its VANISH 303 study, 188 participants were in the treatment arm and 98 were placed in the placebo group.