TOKYO--(BUSINESS WIRE)--Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) announced today 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”) (STO: CAMX). 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. episil® oral liquid is a medical device class 1 in Europe and a 510(k) registered medical device in the U.S.
For more information about episil®, please access Camurus AB, episil® website: https://www.episil.net/
Solasia is a specialty pharmaceutical company based in Asia, with a mission of "Better Medicine for a Brighter Tomorrow". In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient's healthy living and to provide treatment options for the healthcare providers.
Additional information is available at http://www.solasia.co.jp/en/