SCYNEXIS, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track and Qualified Infectious Disease Product (QIDP) designations for the intravenous (IV) formulation of SCY-078, SCYNEXIS™ novel antifungal product, for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis. SCYNEXIS is currently conducting a Phase 1 study of the IV formulation of SCY-078 to evaluate the safety, tolerability and pharmacokinetics of single-rising doses. The FDA granted QIDP and Fast Track designations for the oral formulation of SCY-078 for both the treatment of invasive candidiasis and invasive aspergillosis in 2014.

The oral formulation is currently in Phase 2 development for both invasive candidiasis and vulvovaginal candidiasis. The FDA's Fast Track Drug Development Program is a process designed to facilitate the development and expeditious review of drugs to treat serious conditions and fill unmet medical needs. This designation allows for companies to interact with the FDA review team frequently to discuss critical development issues such as study design, required safety data necessary to support approval, and structure and content of a New Drug Application (NDA).

Additionally, should the FDA determine that a Fast Track product may be effective after their preliminary evaluation of clinical data submitted by a sponsor, the FDA may also consider reviewing portions of a marketing application before the sponsor submits the complete application, known as a œrolling NDA.