BRIEF—Scynexis submits NDA for vaginal yeast infection drug

US biotech Scynexis has submitted a New Drug Application (NDA) to the US Food and Drug Administration for oral ibrexafungerp for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection.

With only one approved oral therapy, which is not safe for pregnant women who are prone to yeast infections and increasing resistance to the therapy, this could be a potential treatment alternative.

Ibrexafungerp is a broad-spectrum antifungal agent representing the first novel therapeutic class in more than 20 years, and unlike some current treatments which only slow fungal growth, it kills the fungus.

The submission is supported by positive results from two Phase III studies in which oral ibrexafungerp demonstrated statistical superiority over placebo with a favorable tolerability profile.

Based on FDA timelines, Scynexis expects to receive notification if the NDA has been accepted for filing and substantive review in December 2020.