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.