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FDA Approves Solosec for Bacterial Vaginosis
The FDA has approved secnidazole (Solosec, Symbiomix Therapeutics) 2 g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Secnidazole is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that has been shown to be efficacious and well tolerated. Secnidazole is the first single-dose oral therapy for BV and the first new oral antibiotic to treat BV in more than a decade.
BV is the most prevalent gynecological infection in the U.S., affecting 21 million women ages 14 to 49 years annually. The most commonly prescribed oral BV treatment regimen requires twice-a-day dosing for seven days. Adherence with the current leading therapy for the treatment of BV has been shown to be only about 50%.
Support for the FDA approval included two pivotal trials in BV and an open label safety study. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events.
The FDA designated secnidazole a qualified infectious disease product for the treatment of BV and granted it a fast track designation, which made the medication eligible for priority review and at least 10 years of U.S. market exclusivity.
The entire contents of the secnidazole packet should be sprinkled onto applesauce, yogurt, or pudding and consumed within 30 minutes without chewing or crunching the granules. The medication is not intended to be dissolved in any liquid.
Symbiomix expects the medication to be available to patients in the first quarter of 2018.
Source: Symbiomix Therapeutics, September 18, 2017.