Updated on 18 May 2016
Japanese pharmaceutical company that specializes in oncology, Solasia Pharma K K has filed a New Medical Device Application for episil (SP-03) in Japan and China. episil oral liquid is indicated for the local treatment of pain associated with oral mucositis (OM).
The company says that the drug was developed using an award-winning Camurus proprietary technology FluidCrystal. episil is administered as a lipid-based liquid that spreads on the intra-oral mucosal surfaces and transforms to a strongly bioadhesive film that mechanically protects the sensitized and sore mucosa of the oral cavity.
Clinically demonstrated, episil has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. episil oral liquid is the only product for OM that is supplied as a ready-to-use, pocket-sized device helping patients maintain their quality of life while undergoing cancer therapy.
episil was first launched in Europe in 2009 and is today commercially available in a number of countries, including the US where it was launched by key global pharmaceutical players. episil oral liquid is a medical device class 1 in Europe and a 510(k) registered medical device in the US.
Solasia acquired exclusive commercialization rights in Japan and China to episil from Camurus and had been developing since.