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Phase III trial of Tilidine in China complete

China Aoxing has completed its phase III trial of Tilidine for the relief of acute, and moderate to severe pain as well as chronic cancer-related pain

Headquartered in Shijiazhuang City, China Aoxing, which specialises in research, development, manufacturing and distribution of narcotic and pain-management products, has completed its phase III clinical study for Tilidine tablets. The drug is an orally-absorbed synthetic narcotic analgesic in 50mg or 100mg dosage strength for relief of acute, moderate to severe, and chronic cancer-related pain.

Mainly used in European countries, including Germany, Belgium, Ireland, Italy and Switzerland, it is designated as a Class III New Medicine in China, meaning it will have at least four-year market exclusivity protection upon marketing clearance by China's State Food and Drug Administration (SFDA).

"Reaching this pivotal milestone is an important event for the development of our Tilidine franchise, and will enable a complete analysis of the trial results and a timely submission of new drug application (NDA) to the China SFDA," said Zhenjiang Yue, CEO and chairman of China Aoxing. "We believe that Tilidine has the potential to become a major player in the underserved pain market in China. Also, we are looking forward to reporting the top-line results in the coming weeks."

An estimated 50 million operation procedures are performed in hospital and clinical centres in China every year, 50 per cent of which require acute post-operative pain treatment. Additionally, an estimated 2.2 million new cancer patients are diagnosed every year, and 60 per cent of these are unable to receive necessary pain management under the current treatment paradigm. According to the New England Journal of Medicine, cancer accounts for 20 per cent of adult deaths in China and is the leading cause of death in the country.

 

 

25th January 2010

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