FDA Approves Ibrexafungerp for Vaginal Yeast Infection

First Drug in New Antifungal Class

Marcia Frellick

June 02, 2021

The US Food and Drug Administration (FDA) has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy 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, formally known as vulvovaginal candidiasis (VVC), in more than 20 years, the drug's manufacturer Scynexis said in a press release. It becomes the first and only non-azole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated 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 agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis says, is the only other orally administered antifungal approved for the treatment of VVC in the US and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company notes, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the the company notes ibrexafungerp should not be used during pregnancy, and administration during pregnancy "may cause fetal harm based on animal studies."

Because of possible teratogenic effects, the company advises clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can be come with substantial morbidity, including genital pain, itching and burning,  reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Angulo said the drug "has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022."

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support US marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA's Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the US for 10 years.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

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