New drug for vaginal yeast infections approved by the FDA


(HealthDay): A new and expensive antifungal drug to treat vaginal yeast infections was approved this week by the U.S. Food and Drug Administration, but critics say it’s not necessary.

Brexafemme (ibrexafungerp) is a one-day oral treatment and the first in a new class of triterpenoid antifungal drugs. The drug kills candida, the which causes a vaginal infection, according to the drug manufacturer SCYNEXIS, The New York Times reported. The current standard oral drug, Diflucan (fluconazole), inhibits yeast growth but does not kill it.

“This approval of a new antifungal drug provides an additional treatment option for patients with vulvovaginal candidiasis or vaginal or vulvar yeast infections, and represents another step forward in the FDA’s overall efforts to ensure safe and effective efficacy. are available to patients, ”Sumathi Nambiar, MD, MPH, director of the FDA’s Antiinfections Division, said in a statement.

But price is an issue. The estimated list price for a Brexafemme four-tablet treatment will range from $ 350 to $ 450, said David Angulo, MD, medical director of SCYNEXIS. The average retail price of fluconazole on GoodRx is $ 29.81 Time reported. It is not clear what the new it is even needed, added Denise Jamieson, MD, MPH, president of gynecology and obstetrics at Emory University School of Medicine in Atlanta. “I don’t see a lot of resistance,” he told Time. “I really can’t comment on whether this will be a big addition or not. It’s always helpful to have another option, and then you’ll have to consider aspects like cost and tolerability.”

A clinical trial used to support FDA approval showed 50% efficacy at 10 days after treatment and 60% at 25 days after treatment Time was reported and another trial showed 64% efficacy on day 10 and 73% on day 25.

FDA: Fluconazole is associated with an increased risk of miscarriage

More information:
New York News Article

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Citation: New FDA-approved vaginal yeast infection drug (2021, June 4), retrieved June 5, 2021 at -fda.html

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