Home Uncategorized Sinexis antifungal drug secures FDA approval; First approval in new class...

Sinexis antifungal drug secures FDA approval; First approval in new class in 20 years

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Available treatments for vulvovaginal candidiasis, more commonly known as a vaginal yeast infection, include intravenous and antifungal medications in pill formulation. But fungi are developing resistance to these older drugs, making them less effective. FDA this week Approved An antifungal, from Sinexis, offers a new treatment option that also represents the first new antifungal drug class in 20 years.

Sinexis antifungal, ibrexafungerp, is available as a pill. It will provide an alternative to fluconazole, a decades-old antifungal that is the only other oral antifungal available to treat vaginal yeast infections. Jersey City, New Jersey-based Cynexis will market its drug—the company’s first FDA-approved product—under the trade name “Brexfem.”

Antifungal drugs work by interfering with some key part of a fungal cell. Brexafemme blocks glucan synthase, an enzyme that is an essential component of the fungal cell wall. The 2001 FDA approval of echinocandins made that class of antifungals the newest as of this week. Those drugs also block glucan synthase. But echinocandins are administered intravenously so they must be given in a clinical setting. As a pill, Brexafemme can be taken in the hospital or at home. The recommended dosage is four tablets taken a day—two 150 mg tablets taken in the morning and then two more 150 mg tablets taken approximately 12 hours later.

Fluconazole, the other oral drug approved by the FDA to treat yeast infections, targets a different enzyme. Brexafemme’s . According to prescribing informationThe drug retains its antifungal activity at 4.5 pH which is the normal vaginal pH level. The paperwork also notes that Brexafemme retains its activity against most species. candida Fungi that have developed resistance to fluconazole.

The FDA based its Brexafemme approval decision on the results of two placebo-controlled Phase 3 studies, which jointly enrolled more than 500 patients. The main goal was to measure the percentage of patients who achieved a clinical cure—complete resolution of signs and symptoms of infection. according to a synaxis investor presentation, 50.5% of patients achieved that goal in the first phase 3 study, compared to 28.6% of patients given placebo. In the second phase 3 clinical trial, 63.3% of patients achieved the main study goal, compared to 44% of patients who received placebo. Those results were statistically significant.

In all clinical trials of the Brexafemme trial, Cynexis reported no systemic problems associated with its drug. Most of the reported treatment-related adverse events were gastrointestinal (diarrhoea, nausea, abdominal pain); 85% of them were classified as mild and half of them lasted a day or less.

Skenexis discovered ibrexafungerp as part of a research collaboration with Merck. Following a review of its infectious diseases portfolio, the pharma giant transferred all its rights to the program to Cynexis in 2013. Under the agreement, Cynexis will have to pay Merck royalties from sales of its drug.

The FDA’s approval of Brexafemme enabled Cynexis to outperform several other biotechs on the market with an oral alternative to older antifungals used to treat vulvovaginal candidiasis. Durham, North Carolina-based Mycovia Pharmaceuticals has upgraded its pill, oteseconazole, through critical testing and expects to file for FDA approval in the first half of this year. Amplyx, a San Diego-based antifungal biotech with a novel antifungal candidate in mid-stage clinical development Acquired by Pfizer earlier this year. No financial terms of the acquisition were disclosed.

Cynexis will commercialize Brexafem through a partnership with Amplity Health, a contract commercialization organization. The drug is expected to launch in the second half of this year.

Additional Cynexis studies that may expand the label of Brexafemme are underway. The company is conducting a phase 3 clinical trial testing the drug as a preventive measure for recurrent vulvovaginal candidiasis; The company expects to file a complementary new drug application for that indication in the first half of next year.

photo by flickr user Ed Uthman via creative commons License

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