Solasia Pharma K.K. announced that episil (SP-03) has been approved for the management of pain and relief of pain, soothing oral lesions including oral mucositis/stomatitis caused by chemotherapy and/or radio therapy by the Ministry of Health, Labour and Welfare.

Solasia will target to obtain reimbursement of episil and thereafter be commercialized, distributed and promoted by its partner, Meiji Seika Pharma K.K.

Episil oral liquid is the first approved product in Japan for local treatment of pain associated with oral mucositis (OM) for cancer patients undergoing chemotherapy and radiotherapy.

 In 2016, Solasia has obtained an exclusive license to develop and commercialize episil in Japan and China from Camurus AB (“Camurus”). In May 2016, Solasia filed for New Medical Device Application for episil in China.

Episil was developed using Camurus’s 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 U.S. where it was launched by key global pharmaceutical players.