Rapid relief of pain in oral mucositis, New episil oral liquid approved in China

Solasia Pharma K.K. (TOKYO:4597, Headquarters:Tokyo, Japan, President & CEO:Yoshihiro Arai, hereinafter "Solasia"), a specialty pharmaceutical company based in Asia, today officially announced that episil® oral liquid (SP-03, hereinafter "episil®") has been approved by the National Medical Products Administration (NMPA, formerly CFDA) in China to relieve pain in the oral cavity, soothing lesions caused by chemotherapy and/or radiotherapy. As the only ready-to-use, pocket-sized medical device for managing and relieving oral mucositis, episil® will provide a new treatment option for patients with oral mucositis in China. Especially for cancer patients undergoing radiotherapy and/or chemotherapy, episil® can effectively reduce the severity of oral mucosal inflammation and significantly improve compliance and convenience of cancer patients during the entire chemo/radiotherapy.

Oral mucositis (OM) is a common side effect, which occurs in 20%-40% of chemotherapy, approximately 80% of high-dose chemotherapy (such as hematopoietic stem cell transplantation pretreatment) and most of head and neck cancer patients receiving radiotherapy. 1,2 OM usually manifests as redness, erosion, ulcers and pain, affecting swallowing and eating and often leads to decreased dose, interruption or delay of radiotherapy, and even hospitalization. OM seriously affects patients' quality of life, treatment progress and efficacy. At present, there is a lack of fast, effective, safe and comfortable product for OM caused by cancer radiotherapy and chemotherapy, so the unmet needs are urgent and huge. Currently, there is no standard treatment with clear effect in China. Mouth care guidance and support by UK Oral Mucositis in Cancer Group (UKOMiC)3 and European Oral Care in Cancer Group (EOCC) oral care guidance and support4 recommend the use of episil® to prevent the occurrence of oral mucositis and relieve pain.

episil® uses the patented FluidCrystal® technology from Camurus AB, Sweden. It is a lipid-based, preservativefree fluid that adhere to the oral mucosa, and form a layer of protective membrane within 5 minutes after contacting with the oral mucosa. 5 It provides physical protection to the oral sensitive and ulcerated epithelium and relieves pain for up to 8 hours.5,6

China registry trial 7 compared episil® with commercially available oral rinse in cancer patients with OM caused by chemotherapy and/or radiotherapy and evaluated the efficacy, safety and mucoadhesiveness of episil®. The results showed that single use of episil® significantly decreased the oral mucosal pain score within 6 hours, and the local analgesic effect and duration effect were superior to control group; in addition, episil® was easy to adhere to the mucosa and the film formation time was fast (within 5 minutes). Patients reported the taste as pleasant, comfortable, without irritation and they were willing to accept its treatment. This trial has confirmed the efficacy and safety of episil® in OM treatment.

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 China, Japan and other Asian countries. The approval of episil® will help Solasia to deliver its unwavering commitment to Chinese 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."

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