JERSEY CITY, N.J., Dec. 01, 2021 (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 that BREXAFEMME® (ibrexafungerp tablets) has been named as a Popular Science 2021 “Best of What’s New” award winner in the Health category.
“2021 has been an action-packed year of innovation in health care, and we are honored that BREXAFEMME has been recognized alongside major disruptive innovations like the COVID-19 vaccines, a new treatment for Ebola, and other therapies and devices that are improving global health,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “BREXAFEMME represents the first new antifungal class approved by the U.S. Food and Drug Administration in more than 20 years and the first new treatment approved for vaginal yeast infections in more than 25 years. It is a novel one-day oral treatment option for the millions of women who suffer from yeast infections and works by killing the fungi causing the infection. We are thrilled to have this groundbreaking product recognized for its innovation.”
Every year since 1988, the editors of Popular Science have reviewed thousands of products in search of the top 100 innovations—breakthrough products and technologies that represent significant advancements in their categories. Best of What’s New awards are presented to products and technologies in 10 categories: Aerospace, Automotive, Engineering, Entertainment, Gadgets, Health, Home, Personal Care, Sports & Outdoors, and Security.
About BREXAFEMME® (ibrexafungerp tablets)
BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells.1 The New Drug Application (NDA) for BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.2
INDICATION
BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).
DOSAGE AND ADMINISTRATION
The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food.
IMPORTANT SAFETY INFORMATION
- BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
- BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
- When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, visit www.brexafemme.com. Please click here for full Prescribing Information.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS launched its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets), which was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Media Relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
ggasaatura@lifescicomms.com
1 BREXAFEMME® U.S. prescribing information. June 2021.
2 Nosanchuk JD. Current status and future of antifungal therapy for systemic mycoses. Recent Pat Antiinfect Drug Discov. 2006 Jan;1(1):75-84. doi: 10.2174/157489106775244109. PMID: 18221136. https://pubmed.ncbi.nlm.nih.gov/18221136/ Accessed September 7, 2021.
