June 3, 2021 -- The FDA has approved a new drug for vaginal yeast infections, something 3 out of every 4 women encounter at least once in their life.
Ibrexafungerp is the first drug approved in a new antifungal class for the condition, in more than 20 years, the drug's manufacturer Scynexis said in a press release. It is the first drug that does not use a type of antifungal known as azoles to treat vaginal yeast infections.
The company said approval came after positive results from two phase III studies in which an oral version of the drug showed efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.
There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved treatments include several topical antifungals and the oral antifungal fluconazole, which, Scynexis says, is the only other orally administered antifungal approved in the U.S. and has accounted for more than 90% of prescriptions written for the condition each year.
According to The New York Times, drug is expected to cost $350 to $450 for the four-tablet treatment. By comparison, GoodRx lists the average retail price of fluconazole as $29.81.
Michael Carome, MD, director of Public Citizen’s Health Research Group, told the Times, “This drug is not necessary and few women should need it. Fluconazole is available at very low cost and in general is very effective. The cost of this is just outrageous.”