China Aoxing Completes Trial of Pain Drug
ChinaBio Today submits:
China Aoxing Pharmaceutical Company (CAXG.OB) has completed its Phase III trial of Tilidine tablets, an synthetic oral narcotic drug that treats acute and chronic moderate to severe pain, including post-operative and cancer pain. The drug, which is not currently available in China, is a Class III New Medicine that will enjoy at least four years of market exclusivity protection, post-approval.
The Phase III clinical study was a multi-center, randomized, double-blind and active-control study which included two pivotal trials: (1) a trial of 200 patients with post-operative pain for the indication of acute moderate to severe pain; (2) a trial of 120 patients with cancer pain for the indication of chronic moderate to severe pain. The primary endpoints used to evaluate the efficacy were the sum of pain score differences, measured by Pain Intensity Difference (PID). However, the company said the size of the trials per protocol was not powered to achieve statistical significance between the treatment arms versus control arms.