China Aoxing Completes Codeine Product Trial

China Aoxing Pharmaceutical Company (CAXG.OB) reported that it has completed the registration trial of Codeine Phosphate, an oral solution that treats acute moderate to severe cough. The company plans to announce top-line results from the trial by the end of Q3 of 2009.

China Aoxing said the drug falls under the Class III New Medicine designation, which means it is the first such compound to be launched in China, although it is already available as a regulated drug in other countries. As such, it is eligible for at least three-year market exclusivity protection following SFDA clearance. The company expects to launch its codeine product in China in 2010, assuming positive trial results.

This registration trial was a randomized, multi-center, double-blind, positive-controlled study. It was designed to evaluate the efficacy of a compound oral solution of codeine phosphate in 215 patients with acute moderate to severe cough.

Liying Yang, Vice President of Research of China Aoxing, said the drug showed efficacy and safety in the trial, though he did not release any specific data.

China Aoxing focuses on narcotic and pain-management products; it is one of a relatively few China pharmas that has SFDA sanction to produce narcotic drug products.

In April 2008, American Oriental Bioengineering (NYSE: AOB) paid $18 million for a 38% stake in China Aoxing. The two companies agreed to work together to bring new products to market and to increase sales of China Aoxing’s existing products.

Disclosure: none.