FDA approves novel antifungal treatment for vaginal candidiasis

Ibrexafungerp is a triterpenoid antifungal that works by inhibiting the formation of the fungal cell wall. Ibrexafungerp (pronounced eye-BREX-ah-FUN- jerp) is the first approved drug of a novel class of antifungals.

Efficacy

Two randomized placebo-controlled positive for Candida albicans. Participants clinical trials evaluated the safety and received two 150-mg tablets (300-mg dose) efficacy of ibrexafungerp. Participants were of ibrexafungerp or placebo 12 hours apart postmenarche, nonpregnant females with VVC. In trials, a diagnosis of VVC is defined as a minimum composite vulvovaginal signs and symptoms (VSS) score greater than or equal to 4 and a minimum of 2 moderate signs or symptoms (score of 2 or greater), positive microscopic examination in a sample demonstrating yeast, and a normal vaginal pH. Signs and symptoms were scored along a scale: 0 (absent) to 3 (severe). Median VSS scores at baseline in trials 1 and 2 were 9 and 10, respectively, at baseline; range, 4 to 18. In both trials, the majority of cultures were in a single day, a total daily dose of 600 mg. Participants were reassessed at a test-of-cure (TOC) visit between days 8 to 14 and a follow-up visit between days 21 to 29. Participants with a positive culture for Candida who had at least 1 dose of the study drug were included in a modified intention to treat analysis. Compared with placebo, a greater percentage of participants on ibrexafungerp demonstrated negative cultures at the TOC visit (P < .001) and VSS scores of 0 (ie, complete clinical response) at the TOC (P = .001 and .009) and follow-up visits (P = .007 and .006).

Safety

In trials, a total of 545 participants were exposed to a dose of ibrexafungerp. The most common adverse effects (AEs) noted in participants administered ibrexafungerp are diarrhea (16.7%), nausea (11.9%), abdominal pain (11.4%), dizziness (3.3%), and vomiting (2.0%). For comparison, the most common AE noted in participants administered placebo in trials is abdominal pain (5.1%). Ibrexafungerp is metabolized by cytochrome P450 (CYP3A). Concomitant administration of strong inhibitors or moderate to strong inducers of CYP3A may alter the patient’s exposure to ibrexafungerp. A reduced dose of ibrexafungerp, 150 mg (1 tablet), should be given when concomitantly administered with strong CYP3A inhibitors. Ibrexafungerp is potentially teratogenic. The use of ibrexafungerp is contraindicated in pregnant women. A patient’s pregnancy status should be confirmed prior to use. The manufacturer recommends the use of contraception for 4 days after the last dose of ibrexafungerp for all women of reproductive potential. If a woman is pregnant or pregnancy is detected within 4 days after the last dose of ibrexafungerp, patients should report the pregnancy to the manufacturer to include in an ongoing safety analysis by calling 1-888- 982-7299.

Dosing

The recommended dosage of ibrexafungerp for treatment of VVC is 300 mg. This dose is provided as two 150-mg tablets. To complete a full course of therapy, patients should take two 150-mg tablets for the first dose and two 150-mg tablets 12 hours later. This medication may be taken with or without food.

Reference

1. Brexafemme. Prescribing Information. Scynexis, Inc; 2021. Accessed June 14, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214900s000lbl.pdf

This article was originally published in Drug Topics®.