episil® oral liquid(SP-03)

Initial indication
Pain associated oral mucositis (Medical Device)
PIPELINES INDICATION AREA PRE-
CLINICAL
CLINIAL STUDY NDA APPROVAL
/LAUNCH
PROGRESS PARTNER
PHASE 1 PHASE 2 PHASE 3

episil® oral liquid(SP-03)

Pain associated oral mucositis [Medical Device] Japan
Launched in 2018

Meiji Seika Pharma:

Japan

 

Solasia sales force:

Beijing, Shanghai, Guangzhou

 

Lee’s Pharma:
China Mainland w/o above 3 cities

 

Synex
South Korea

China
Launched in 2019
South Korea
Launched in 2020

SP-03

In March 2015, Solasia acquired exclusive commercialization rights in Japan and China to SP-03 from Camurus, also acquired South Korea right in August 2018. SP-03(episil®) 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, episil® forms a protective film within a few minutes, which acts as a mechanical barrier and provides relief of pain suffered from oral mucositis. episil® was developed using the award-winning Camurus proprietary technology FluidCrystal®. Clinically demonstrated, episil® has been shown immediate (within minutes) and effective pain relief which lasted 8 hours*. episil® is supplied as a ready-to-use, pocket-sized device helping patients improve their quality of life while undergoing chemotherapy and/or radiotherapy. FluidCrystal® was awarded the “Best innovation in formulation” prize at the CPhI Worldwide in 2013.

* Hadjieva, T et al. Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution. Support Care Cancer 2014, 22:1557–1562

Development Status: Launched in Japan, China, and South Korea

In Japan, episil® was approved in July 2017, launched by Solasia’s commercialization and promotion partner, Meiji Seika Pharma Co., Ltd. in May 2018.
In China, episil® was approved in February 2019, and launched in July 2019.
In South Korea, episil® was approved in October 2019, and has been launched in September 2020.

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