The Food and Drug Administration on Tuesday approved a new drug to treat a vaginal yeast infection that is especially common in women who are pregnant, using birth control pills or taking antibiotics.
The drug, Brexafemme (ibrexafungerp) made by SCYNEXIS, is a one-day oral treatment and the first of a new class of triterpenoid antifungal drugs. The company said the new drug kills candida — the yeast that can cause an infection.
The standard oral medication, Diflucan (fluconazole), inhibits the growth of yeast but does not kill it.
But the treatment most likely wouldn’t be prescribed widely at first for common vaginal yeast infections. Dr. David Angulo, the company’s chief medical officer, estimated that the list price of the drug would range from $350 to $450 for the four-tablet treatment. By comparison, GoodRx lists the average retail price of fluconazole as $29.81.
He said Brexafemme was approved as a first-line treatment, but could also be prescribed for patients whose infections don’t clear up easily.
“There has been nothing new that can be provided to patients who can’t tolerate it, don’t respond well or develop resistance,” Dr. Angulo said.
Dr. Sumathi Nambiar, director of the F.D.A.’s division of anti-infectives said: “This approval for 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 F.D.A.’s overall efforts to ensure safe and effective antifungal drugs are available to patients.”
Dr. Denise Jamieson, chair of gynecology and obstetrics at Emory University School of Medicine, said she wasn’t sure the new drug was needed.
“I don’t see a tremendous amount of resistance,” she said. “I can’t really comment on whether this is going to be a large addition or not. It’s always helpful to have another option, and then you have to consider things like cost and tolerability.”
According to Dr. Angulo, one clinical trial used to support the application showed 50 percent efficacy — meaning complete resolution of all signs and symptoms — at 10 days after treatment and 60 percent 25 days after treatment. The other trial showed 64 percent efficacy at day 10 and 73 percent at day 25.
Dr. Michael Carome, director of Public Citizen’s Health Research Group, was not impressed by the F.D.A.’s approval of Brexafemme.
“This drug is not necessary and few women should need it,” Dr. Carome said. “Fluconazole is available at very low cost and in general is very effective. The cost of this is just outrageous.”
The F.D.A. is requiring SCYNEXIS to conduct several post-market studies, including one to assess the risks to pregnant women, the developing fetus and newborns; and another to study how much of the product goes into the breast milk of lactating women.
The drug will go on sale later this year.