China Aoxing Wins OK for Narcotic Drug Trial

China Aoxing Pharmaceutical Company (CAXG.OB) received SFDA approval to begin a clinical trial of Tilidine/Naloxone capsules, a narcotic drug for moderate to severe pain. The drug is given to alleviate cancer and post-surgical pain. China Aoxing plans to begin the clinical trial by the end of this year, and expects to receive final approval of the drug in 2011. As a Class III New Medicine, it will be given at least three years of market exclusivity protection following SFDA approval.

Tilidine/Naloxone capsules combine Tilidine, a mild synthetic opioid, with Naloxone, an opioid antagonist that deters abuse of the product. When taken as directed, the Tilidine/Naloxone capsules provide relief from pain, and the Naloxone passes through the body without apparent effect. However, if the capsules are crushed or dissolved in alcohol, both of which are common procedures among abusers of opioids, the Tilidine and Naloxone are released together, which significantly reduces the euphoric effect of Tilidine.

China Aoxing is one of a relatively few pharmaceutical companies in China to have a license to investigate and produce narcotic products. In early 2008, China Aoxing established a strategic alliance with American Oriental Bioengineering (NYSE: AOB) to develop and market narcotic drugs in China. American Oriental paid $18 million for a 38% stake in China Aoxing.

Disclosure: none.