China Aoxing Pharmaceutical Company has received formal approval from the China State Food and Drug Administration (SFDA) for the clinical study of Codeine Phosphate Compound Medicine for the treatment of cold and flu.
While Codeine Phosphate is widely used and considered effective in cold and flu treatment in Western countries, it just became available in China in 2006. The company will commence a clinical study of the Codeine Phosphate Compound Medicine in the early fall of 2007 to test efficacy and safety in China. The clinical study is a multi-center randomized, double-blind, controlled trial, involving 300 patients, and is expected to be completed in early 2008.
Codeine Phosphate is an effective opioid cough medicine in Western countries, which just became available in China in 2006. China Aoxing is developing an oral solution consisting of Guaifenesin, Pseudoephedrine Hudrochloride and Codeine Phosphate. Codeine Phosphate is widely prescribed in continental Europe and other regions, including major markets like Australia, New Zealand and Canada. It is also available without prescription in combination preparations in limited doses in some countries.