Scynexis submits NDA for oral ibrexafungerp for vaginal yeast infection
Scynexis announced today that it has submitted a new drug application to the FDA for oral ibrexafungerp for the treatment of vulvovaginal candidiasis, the second most common cause of vaginitis.
“The submission of this NDA marks the next step toward bringing the first new class of oral antifungals in over 20 years to women suffering from vaginal yeast infections and their health care providers, who, to date, have had only one class of medications,” Scynexis President and CEO Marco Taglietti, MD, said in a press release. “We believe that ibrexafungerp may be the modern antifungal therapy that will have utility for a broad range of today’s fungal infection patients as fluconazole did almost 30 years ago.”
Scynexis said the submission is supported by two phase 3, double-blind, placebo-controlled trials that showed ibrexfungerp had statistical superiority over a placebo, as well as a favorable tolerability profile.
The drug has also received fast-track designation by the FDA, which will allow it to receive priority review and may expedite the review process to 6 months.