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

Initial indication: local treatment of pain associated with oral mucositis caused by
chemo and 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
    US, EU, over 6 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
US, EU, over 6 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 represents a unique and innovative concept for local treatment of pain associated with oral mucositis (OM). Developed using the award-winning* Camurus proprietary technology FluidCrystal®, SP-03 is administered as a lipid-based liquid that spreads on the intraoral mucosal surfaces and transforms to a strongly bioadhesive film that mechanically protects the sensitized and sore epithelium of the oral cavity. Clinically demonstrated, SP-03 has been shown to rapidly (within minutes) and effectively reduce oral pain for up to 8 hours. SP-03 is the 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. SP-03 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. SP-03 is a medical device class 1 in Europe and a 510(k) registered medical device in the U.S. *FluidCrystal® was awarded the “Best innovation in formulation” prize at the CPhI Worldwide in 2013.

Development Strategy:Approved in Japan, Waiting for approval in China

Obtained Approval of SP-03 (episil®) in Japan as New Medical Device on July 2017. New Medical Device Application (NMDA) have 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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