China SFDA approves clinical trial of China Aoxing's abuse resistant opioid drug

Sep 17 2009

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced that its Clinical Trial Application ("CTA") for Tilidine/Naloxone Capsules, an opioid drug with abuse resistance property, was officially approved by the China State Food and Drug Administration ("SFDA"). CTA approval is a key SFDA requirement prior to pursuing a clinical trial and, ultimately, commercialization of a pharmaceutical product in China. The company hopes to begin the clinical trial by the end of this year, and estimates that receipt of a market license could occur sometime in 2011. The drug is designated as a Class III New Medicine with approximately at least three-year market exclusivity protection upon marketing clearance by the China SFDA.

Tilidine/Naloxone Capsules were developed with China Aoxing's proprietary technology, which combines Tilidine, an effective opioid agonist, with Naloxone, an opioid antagonist, to address moderate to severe pain, such as cancer pain and post-operative pains. Based on clinical trials in Europe, when Tilidine/Naloxone Capsules were taken as directed, pain relief was provided and Naloxone passed through the body without observed clinical effect. If the Capsules is crushed or dissolved in alcohol, which are common approaches abusers use to tamper with an opioid product in order to gain euphoria, both Tilidine and the Naloxone are released, and the euphoric effect of Tilidine was significantly reduced.

"Today's announcement speaks to our unique capability to commercialize narcotic pharmaceutical products in the Chinese market," stated Zhenjiang Yue, Chairman and CEO of China Aoxing. "CTA acceptance is one key step toward reaching marketability. To the best of our knowledge, we could be the first pharmaceutical company to bring Tilidine/Naloxone Capsules to China. This is a great example of our ability to target under-penetrated areas with drugs that improve the overall health of the population. We remain excited about the growth prospects for abuse resistant painkiller in China, which just becomes a new therapeutic paradigm in developed countries. We intend to continue to bring high value, niche-focused prescription drugs, with rigor and prudence, to the growing Chinese healthcare market."