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FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.
In May 2015, FDA approved Raplixa, the first spray-dried fibrin sealant. Raplixa is used to help control bleeding in adults during surgery. The approval was based on a Phase III, multicenter clinical trial involving 721 patients who underwent different surgical procedures across four countries. Clinical supplies of Raplixa were manufactured by Nova Laboratories at its sterile manufacturing facilities. The product comprised of spray-dried thrombin and spray-dried fibrinogen, which are blended and filled aseptically.
Raplixa needs no thawing, reconstitution, or mixing, and can be applied directly from the vial or with a device. The Raplixa spray device, also approved by FDA, is a low-pressure spray applicator that can be used to apply the fibrin sealant to the bleeding site where the product then dissolves in the blood and starts a reaction between the two proteins, leading to clotting of the blood to help stop bleeding. The approval of Raplixa provides surgeons with an extra option to control bleeding during surgery when needed.
The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial, eliminating the need to mix the fibrinogen and thrombin before use, and allowing the product to be stored at room temperature. Commercial supplies of Raplixa are now being manufactured by Nova Laboratories.
Article DetailsPharmaceutical Technology
Vol. 40, No. 7
When referring to this article, please cite it as S. de Costa, “Raplixa case study: Enabling an innovative drug presentation through aseptic spray drying” sidebar to “Exploring the Use of Aseptic Spray Drying in the Manufacture of Biopharmaceutical Injectables," Pharmaceutical Technology 40 (7) 2016.