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news.China Aoxing Pharmaceutical (China Aoxing) has completed phase III clinical study for Tilidine tablets, to treat acute and chronic moderate to severe pain, including post-operative and cancer pain in adult patients.
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The company said that the drug is designated as a Class III New Medicine with approximately at least four-year market exclusivity protection, upon marketing clearance by the China SFDA.
The phase III clinical study was a multi-center, randomised, double-blind and active-control study which covers two pivotal trials. They are: a trial of 200 patients with post-operative pain for the indication of acute moderate to severe pain; and a trial of 120 patients with cancer pain for the indication of chronic moderate to severe pain.
Reportedly, the study was conducted at 9 metropolitan hospitals in China. The primary endpoints used to evaluate the efficacy were the sum of pain score differences, measured by Pain Intensity Difference (PID). The size of the trials per protocol was not powered to achieve statistical significance between the treatment arms versus control arms.
Zhenjiang Yue, chairman and CEO of China Aoxing, said: “Reaching this pivotal milestone is an important event for the development of our Tilidine franchise, and will enable a complete analysis of the trial results and a timely submission of new drug application (NDA) to the China SFDA. We believe that Tilidine has the potential to become a major player in the underserved pain market in China. Also, we are looking forward to reporting the top-line results in the coming weeks.”