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The US Food and Drug Administration (FDA) has approved ibrexafungerp tablets (Brexafem) as a 1-day oral therapy for vaginal yeast infections, it is estimated that 3 out of every 4 women face 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), Scynexis, the drug’s maker, said in a press release. It becomes the first and only non-azole treatment for vaginal yeast infection.
The biotechnology company said the approval comes 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 infection, which is the second most common cause of vaginitis. Those already approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Sinexis says, is the only other orally administered antifungal approved for the treatment of VVC in the U.S. and more than 90% of those prescribed for it. Prescriptions are conditioned every year. However, the company notes, oral fluconazole reports a 55% therapeutic cure rate on its label, which now includes warnings of potential fetal harm, demonstrating the need for new oral alternatives.
The new drug may not meet that requirement for pregnant women, however, the company notes that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies. Because of potential teratogenic effects, the company advises physicians to verify pregnancy status in women of reproductive potential before prescribing ibrexafungerp and to recommend effective contraception during treatment.
Angulo added that the drug “has a differentiated fungicidal mechanism of action that kills a wide range of Candida species, including azole-resistant strains. We are working on complementing our candle study investigating ibrexafungerp for the prevention of recurrent VVC.” and expect that we will submit a supplemental NDA [new drug application] in the first half of 2022.”
Scynexis said it has partnered with Pennsylvania-based pharmaceutical company Amplity Health to support US marketing of the drug. Commercial launch approval will follow. Ibrexafungerp was granted approval through both the FDA’s Eligible Infectious Disease Product and Fast Track designation. It is expected to be marketed exclusively in the US for 10 years.
