Nucryst Pharmaceuticals Corp. announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for a prescription topical cream containing NPI 32101, the company's patent-protected nanocrystalline silver, as a broad-spectrum antimicrobial barrier.
"NPI 32101 cream represents a new presentation of our patented nanocrystalline silver technology," said Scott H. Gillis, president and CEO, Nucryst Pharmaceuticals Corp. "Gaining FDA clearance is a first step toward marketing our proprietary technology in this new formulation. We are actively exploring commercialisation options and as part of this process, market plans and timing for this product will be determined."
In vitro studies have demonstrated that NPI 32101 cream serves as a broad-spectrum antimicrobial barrier to organisms including Pseudomonas aeruginosa and Staphylococcus aureus, including strains resistant to Methicillin (MRSA). Clinical studies involving more than 600 adults and children have also demonstrated that it has a strong safety profile.
Nucryst Pharmaceuticals develops, manufactures and commercialises medical products that fight infection and inflammation using its patented atomically disordered nanocrystalline silver technology. Smith and Nephew plc sell a range of advanced wound care products under their Acticoat trade mark. Acticoat products incorporate Nucryst's Silcryst coatings and are sold in over 30 countries. Nucryst is also developing pharmaceutical products to address medical conditions that are characterized by both infection and inflammation. The company has developed its proprietary nanocrystalline silver in a powder form for use as an active pharmaceutical ingredient, referred to as NPI 32101.