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SCYNEXIS Announces Positive Results from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections, Clearing the Way for Regulatory Submission and Potential Approval of Additional Indication by End of 2022
Ibrexafungerp, the only fungicidal oral treatment for vaginal yeast infections, successfully achieved statistically significant superiority over placebo for
About this update from Scynexis, Inc.
[{"type":"text","content":"Ibrexafungerp, the only fungicidal oral treatment for vaginal yeast infections, successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.SCYNEXIS will submit a supplemental New Drug Application (sNDA) for BREXAFEMME® (ibrexafungerp tablets) for the prevention of recurrent vaginal yeast infections (rVVC) in the first half of 2022 with anticipated approval by the end of the year.Additionally, a one day treatment of ibrexafungerp achieved a substantial reduction or complete elimination of symptoms in a subset of study patients who failed to respond to a three-day regimen of fluconazole. In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing BREXAFEMME label.SCYNEXIS will host a conference call today, February 10 at 8:30 a.m. ET. JERSEY CITY, N.J., Feb. 10, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced positive results from its global Phase 3 CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (rVVC), also known as vaginal yeast infection. The Company plans to submit the results to the U.S. Food and Drug Administration (FDA) in the first half of 2022 and anticipates receiving approval by year-end. \"Ibrexafungerp is the only oral fungicidal agent to successfully complete pivotal trials in both the acute treatment and prevention of yeast infections. As the only non-azole, we believe ibrexafungerp is changing how yeast infections are treated,\" said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. \"These important results support an additional indication for BREXAFEMME for the prevention of rVVC. This exciting achievement is another step in our efforts to bring to market meaningful and innovative solutions in the fight against a broad range of fungal infections and enhance shareholder value.” This trial was conducted under a Special Protocol Assessment (SPA), a process in which sponsors work with FDA to reach agreement on the design and size of a clinical trial to adequately address scientific and regulatory requirements for a study that could support marketing appr...