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news.Tilidine with Naloxone, to address moderate to severe pain, such as cancer pain and post-operative pains
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China Aoxing Pharmaceutical (China Aoxing) has reported 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).
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.
The company expects to initiate 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.
Zhenjiang Yue, chairman and CEO of China Aoxing, said: “CTA acceptance is one key step toward reaching marketability. We remain excited about the growth prospects for abuse resistant painkiller in China, which just becomes a new therapeutic paradigm in developed countries.”