The Food and Drug Administration on Tuesday a new drug approved to treat a vaginal yeast infection that is especially common in women who are pregnant, using birth control pills or using antibiotics.
The drug, Brexafemme (ibrexafungerp), manufactured 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 which can cause an infection.
The standard oral medication, Diflucan (fluconazole), inhibits the growth of yeast but does not kill it.
However, the treatment is unlikely to be commonly prescribed for common vaginal yeast infections at first. Dr. David Angulo, the company’s chief medical officer, estimated that the list price of the drug would range between $ 350 and $ 450 for treatment with four tablets. By comparison, GoodRx cites the average selling price of fluconazole as $ 29.81.
He said Brexafemme was approved as a first-class treatment, but could also be prescribed for patients whose infections did not clear up easily.
“There was nothing new that could provide patients who could not tolerate it, did not respond well or develop resistance,” said Dr. Angulo said.
Dr Sumathi Nambiar, director of the FDA’s division for anti-infective drugs, said: “This approval for a new antifungal drug offers an additional treatment option for patients with vulvovaginal candidiasis, or vaginal or vulva-yeast infections, and represents more.” a step forward in The overall efforts of the FDA to ensure that safe and effective antifungal agents are available to patients. ”
Dr. Denise Jamieson, chair of gynecology and obstetrics at Emory University School of Medicine, said she was not sure the new remedy was needed.
“I do not see much resistance,” she said. ‘I can not really comment on whether it will be a great addition or not. It is always convenient to have another option, and then you need to consider things like cost and tolerance. ”
According to dr. Angulo showed one clinical trial used to support the application, 50 percent efficacy, meaning that the signs and symptoms were completely resolved, ten days after treatment and 60 percent 25 days after treatment. The other trial showed 64 percent efficacy on day 10 and 73 percent on day 25.
Dr Michael Carome, director of Public Citizen’s Health Research Group, was not impressed by the FDA’s approval of Brexafemme.
“This remedy is not necessary and few women need it,” Dr Carome said. ‘Fluconazole is available at very low cost and is generally very effective. The cost of this is just outrageous. ”
The FDA demands that SCYNEXIS conduct several studies to the market, 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 be offered for sale later this year.