SolasiaPharma has filed a New Medical Device Application for episil oral liquid (SP-03, hereinafter ‘episil’) to the Regulatory Authority in South Korea.
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.”
Source: Company Press Release