Remedies accessible for vulvovaginal candidiasis, extra generally known as vaginal yeast an infection, embody antifungal medication in intravenous and tablet formulations. However fungi are creating resistance to those older medicines, making them much less efficient. The FDA this week accredited an antifungal from Scynexis, offering a brand new therapy possibility that additionally represents the primary new antifungal drug class in 20 years.
The Scynexis antifungal, ibrexafungerp, is obtainable as a tablet. It’s going to present an alternative choice to fluconazole, a decades-old antifungal that’s the solely different oral antifungal accessible for treating vaginal yeast infections. Jersey Metropolis, New Jersey-based Scynexis will market its drug—the corporate’s first FDA-approved product—beneath the commerce title “Brexafemme.”
Antifungal medication work by interfering with some key a part of a fungal cell. Brexafemme blocks glucan synthase, an enzyme that’s a vital part of the fungal cell wall. The 2001 FDA approval of echinocandins made that class of antifungals the latest one till this week. These medication additionally block glucan synthase. However echinocandins are intravenously administered in order that they have to be given in a scientific setting. As a tablet, Brexafemme could be taken in a hospital or at dwelling. The really useful dose is 4 capsules taken in at some point—two 150 mg capsules within the morning after which two extra 150 mg capsules taken about 12 hours later.
Fluconazole, the opposite FDA-approved oral remedy for treating yeast infections, targets a unique enzyme. In line with Brexafemme’s prescribing info, the drug retains its antifungal exercise on the 4.5 pH that’s the regular vaginal pH degree. The paperwork additionally notes that Brexafemme retains its exercise in opposition to most species of Candida fungi which have developed resistance to fluconazole.
The FDA based mostly its Brexafemme approval choice on the outcomes of two placebo-controlled Part 3 research enrolling greater than 500 sufferers mixed. The principle purpose was to measure the share of sufferers that achieved a scientific remedy—an entire decision of the indicators and signs of an infection. In line with a Scynexis investor presentation, 50.5% of sufferers achieved that purpose within the first Part 3 research in comparison with 28.6% of these given a placebo. Within the second Part 3 scientific trial, 63.3% of sufferers achieved the principle research purpose in comparison with 44% of those that acquired a placebo. These outcomes had been statistically vital.
In the entire scientific trials testing Brexafemme, Scynexis reported no systemic issues related to its drug. A lot of the treatment-related opposed occasions reported had been gastrointestinal (diarrhea, nausea, stomach ache); 85% of them had been labeled as delicate and half of them lasted a day or much less.
Scynexis found ibrexafungerp beneath a analysis collaboration with Merck. Following a assessment of its infectious illnesses portfolio, the pharma big transferred all of its rights to this system to Scynexis in 2013. Below the settlement, Scynexis should pay Merck royalties from gross sales of its drug.
The FDA approval of Brexafemme enabled Scynexis to beat a number of different biotechs to the market with an oral various to the older antifungals used to deal with vulvovaginal candidiasis. Durham, North Carolina-based Mycovia Prescription drugs has superior its tablet, oteseconazole, by means of pivotal testing and expects to file for FDA approval within the first half of this yr. Amplyx, a San Diego-based antifungal biotech with a novel antifungal candidate in mid-stage scientific improvement, was acquired by Pfizer earlier this yr. No monetary phrases of the acquisition had been disclosed.
Scynexis will commercialize Brexafemme by means of a partnership with Amplity Well being, a contract commercialization group. The drug is predicted to launch within the second half of this yr.
Extra Scynexis research that would develop Brexafemme’s label are underway. The corporate is conducting a Part 3 scientific trial that’s testing the drug as a preventative measure for recurrent vulvovaginal candidiasis; the corporate expects a supplemental new drug software may very well be filed for that indication within the first half of subsequent yr.
Picture by Flickr person Ed Uthman through a Inventive Commons license