FDA Approves Oral Ibrexafungerp For Treatment of Vulvovaginal Candidiasis

Skylar Kenney, Assistant Editor

Officials with the FDA have approved ibrexafungerp tablets (Brexafemme, Scynexis) for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The approval is based on a pair of Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.1

VVC is the second most common cause of vaginitis, and it is often associated with substantial morbidity. Common adverse effects include significant genital discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. Symptoms of VVC typically include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa, and abnormal vaginal discharge. According to a press release from Scynexis, an estimated 70-75% of women worldwide will have at least 1 episode of VVC in their lifetime, and 40-50% of them will experience multiple episodes.1

Ibrexafungerp is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with VVC. It kills fungal cells via glucan synthase inhibition, and, according to Scynexis, ibrexafungerp is the first and only treatment for vaginal yeast infections which is both oral and non-azole.1

The FDA approval is based on the randomized, double-blind, placebo-controlled, multi-center studies VANISH-303 and VANISH-306, in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.1 In VANISH-306, 63.3% of patients treated with ibrexafungerp met the study’s primary endpoint of clinical cure at the day-10 test of cure visit, which was defined as the complete resolution of all vaginal signs and symptoms. At the day-25 follow-up visit, 73.9% of participants had complete symptom resolution.2

The recommended dosage is 600mg, taken as 2 tablets of 150 mg twice a day for 1 day.1

“Both VANISH phase 3 studies also confirmed ibrexafungerp’s sustained clinical effect at the Day-25 follow-up visit, consistent with findings from the Phase 2b DOVE study,” said David Angulo, MD, chief medical officer of Scynexis, in a press release. “In parallel, we continue to advance our CANDLE phase 3 study testing oral ibrexafungerp for the prevention of recurrent vaginal yeast infections, for which there are no approved therapies, and expect top-line data in this indication in the second half of 2021.”2

The release notes that ibrexafungerp administration during pregnancy may cause fetal harm based on animal studies, and the medication is contraindicated during pregnancy. The most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting.1

REFERENCES

  1. SCYNEXIS announces FDA approval of BREXAFEMME (ibrexafungerp tablets) as the first and only oral non-azole treatment for vaginal yeast infections [news release]. Scynexis; June 2, 2021. Accessed June 2, 2021. https://www.globenewswire.com/news-release/2021/06/02/2240294/0/en/SCYNEXIS-Announces-FDA-Approval-of-BREXAFEMME-ibrexafungerp-tablets-as-the-First-and-Only-Oral-Non-Azole-Treatment-for-Vaginal-Yeast-Infections.html
  2. SCYNEXIS announces positive top-line results from its second pivotal phase 3 study (VANISH-306) of oral ibrexafungerp for the treatment of vulvovaginal candidiasis (vaginal yeast infection) [news release]. Scynexis; April 21, 2021. Accessed June 2, 2021. https://www.globenewswire.com/news-release/2020/04/21/2019183/0/en/SCYNEXIS-Announces-Positive-Top-Line-Results-from-its-Second-Pivotal-Phase-3-Study-VANISH-306-of-Oral-Ibrexafungerp-for-the-Treatment-of-Vulvovaginal-Candidiasis-Vaginal-Yeast-Infe.html