SP-03:Oral Medical Device (episil® oral liquid)

Initial indication: Control and Relief Pain of Oral Mucositis Caused by Chemo or Radiotherapy

    • Pipeline Code
    • Estimated Initial indication
    • Originator
  • Pre-
    clinical
  • Clinical Study
  • NMDA
  • Approval
  • Launch
  • Partner
  • SP-03

    Pain associated oral mucositis

    Camurus AB
  • Japan
    China
    Korea
    US, EU, over 9 countries (episil® by other companies)
  • Meiji Seika Pharma:
    Japan
    Lee’s Pharma:
    China Mainland w/o Beijing, Shanghai, Guangzhou and Taiwan
Pipeline Code
SP-03
Estimated Initial indication
Pain associated oral mucositis
Originator
Camurus AB
  • Pre-
    clinical
  • Clinical Study
  • NMDA
  • Approval
  • Launch
Japan
China
Korea
US, EU, over 9 countries (episil® by other companies)
Partner
Meiji Seika Pharma:
Japan
Lee’s Pharma:
China Mainland w/o Beijing, Shanghai, Guangzhou and Taiwan
SP-03

In March 2015, Solasia acquired exclusive commercialization rights in Japan and China to SP-03 from Camurus. SP-03 is a liquid for protecting and dressing of oral lesions and categorized in non-absorptive liquid medical device. Upon contact with the aqueous fluid in the oral mucosa, SP-03 forms a protective film within a few minutes, which acts as a mechanical barrier and provides relief of pain suffered from oral mucositis. SP-03 was developed using the award-winning* Camurus proprietary technology FluidCrystal®. Clinically demonstrated, SP-03 has been shown immediate (within minutes) and effective pain relief which lasted 8 hours. SP-03 is supplied as a ready-to-use, pocket-sized device helping patients improve their quality of life while undergoing chemotherapy and/or radiotherapy. SP-03 was first launched in Europe in 2009 and is today commercially available in a number of countries, including Japan and U.S., where it was launched by key global pharmaceutical players. SP-03 is registered as a medical device class II in Japan, class I in Europe and a 510(k) in the U.S. *FluidCrystal® was awarded the “Best innovation in formulation” prize at the CPhI Worldwide in 2013.


In Japan, episil® (SP-03) was approvaed in July 2017, has been launched by Solasia’s commercialization and promotion partner, Meiji Seika Pharma Co., Ltd. in May 2018.

Development Strategy: Launched in Japan, Under Review for Approval in China, NMDA Preparation in Korea

New Medical Device Application (NMDA) has been submitted to the Chinese regulatory agency in May 2016.

Expected Target Indications

Oral Mucositis caused by chemo and radiotherapy
Oral Mucositis (OM) is a severe side effect of cancer therapies (chemo and radiotherapy) and is characterized by painful ulceration of the oral mucosa. OM affects nearly all head and neck cancer patients receiving radiotherapy (RT); 30%-75% of patients undergoing chemotherapy; and most patients undergoing conditioning regimens for hematopoietic stem cell transplant. OM is caused by damage to the DNA in the basal epithelial cell lining of the mouth leading to decreased cell proliferation ability. OM can prevent patients from eating, swallowing and speaking, and can limit the dosing and frequency of treatment for cancer. OM often necessitates hospitalization for re-hydration, opiate pain medication and total parenteral nutrition.

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