Today President & CEO of Solasia, Yoshihiro Arai, announced that the Company has filed a New Medical Device Application for episil® oral liquid (SP-03, hereinafter “episil®”) to the Regulatory Authority in South Korea. Solasia is a specialty pharmaceutical company based in Tokyo, Japan.
episil® has a mechanical action indicated for the management of pain and relief of pain in the oral cavity, and is the only ready-to-use, pocket-sized medical device for such indication. As there are currently no standard treatment for oral mucositis which may be caused by chemotherapy and/or radiotherapy, episil® is expected to provide a new pain relief treatment option for patients with oral mucositis in South Korea.
In 2015, Solasia obtained an exclusive license to develop and commercialize episil® in Japan and China from Camurus AB (STO:CAMX). In 2018, Solasia obtained the right for South Korea. In July 2017, episil® was approved in Japan by the Ministry of Health, Labour and Welfare, with the indication for the management of pain and relief of pain, soothing oral lesions including oral mucositis caused by chemotherapy and/or radiotherapy. Following approval, episil® was launched in Japan in May 2018. In China, episil® has been approved by the National Medical Products Administration (NMPA, formerly CFDA) in February 2019.
Yoshihiro Arai, President and Chief Executive Officer, Solasia, said: “Solasia company mission is ‘Better Medicine for a Brighter Tomorrow’. We have always focused on the patients, and striven to develop innovative products to treat cancer and support cancer treatment. We continue to bring ‘quality medicines’ to the market, to benefit more patients in Asian countries. The filing of episil® will help Solasia to deliver its unwavering commitment to South Korean patients. All of team members will continue to work hard to meet the needs of patients and healthcare professionals and embrace new challenges going forward.”
About episil® episil® uses the patented FluidCrystal® technology from Camurus AB (STO:CAMX), Sweden. It is a lipid-based, preservative-free liquid that adhere to the oral mucosa. Clinically demonstrated, episil® has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. It provides physical protection to the oral sensitive and ulcerated epithelium. episil® is the only ready-to-use, pocket-sized medical device that manages and relieves oral mucositis, helping patients improve the quality of their daily lives during cancer treatment. episil® was first registered in Europe in 2009 and is now launched in the United States, Europe, Japan and other countries. episil® oral liquid is registered as Class I medical device in Europe, 510(k) medical device in the United States, and approved as Class II medical device in Japan and China.