SCYNEXIS Announces U.S. Availability of BREXAFEMME (ibrexafungerp tablets), the First New Antifungal Class of Therapy Approved by the U.S. FDA for Vaginal Yeast Infections in More Than 20 Years

• First and only oral non-azole treatment option approved for vaginal yeast infections is now available in pharmacies including cloud-based pharmacy
  
  
• New treatment is fungicidal against Candida species, disrupting the fungal cell wall and killing the fungi causing the infection, rather than only inhibiting its growth

JERSEY CITY, N.J., Sept. 22, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced the U.S. availability of BREXAFEMME (ibrexafungerp tablets), the first and only oral non-azole prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat vulvovaginal candidiasis (VVC), commonly referred to as vaginal yeast infection.

“It’s incredibly exciting for all of us at SCYNEXIS to bring this innovative antifungal treatment to the millions of women across the country who suffer from yeast infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “This approval is just the first step to potentially building a wide-ranging ibrexafungerp antifungal franchise in multiple indications for broad patient community infections and in the hospital setting for life-threatening invasive fungal infections.”

BREXAFEMME, a one-day oral medication consisting of two pills (150 mg each) in the morning and two in the evening, is the first new antifungal class in more than 20 years.¹

Christine Coyne, Chief Commercial Officer of SCYNEXIS, added, “Despite the fact that vaginal yeast infections are extremely common with about three out of four women experiencing them at least once in their life, until now there had been limited advancement in this area of women’s health for decades. BREXAFEMME is a truly new, first-in-class fungicidal triterpenoid antifungal, designed to kill the yeast causing the infection, including azole-resistant strains.”

As part of its commitment to ensuring patient access, SCYNEXIS has implemented programs to remove potential barriers and help patients receive treatment. A co-pay assistance savings program is available for eligible commercially insured patients.

Ibrexafungerp has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of VVC (approved indication) and prevention of recurrent VVC (in late-stage clinical investigation). Under QIDP designation, BREXAFEMME has 10 years of market exclusivity in the U.S., five years of new chemical entity exclusivity plus five additional years of exclusivity extension due to the QIDP designation. BREXAFEMME is also protected by multiple patents, with expected patent protection until at least 2035.