Pregabalin extended-release tablets, a subsidiary of China Resources Shuanghe (600062.SH), completed phase III clinical trials

Zhitong Finance App News, China Resources Shuanghe (600062.SH) announced that recently, China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd. (“Shuanghe Limin”), a wholly-owned subsidiary of the company, completed registration of pregabalin sustained-release tablets for phase III clinical trials.

Test name: Randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of post-herpes zoster neuralgia (PHN). Purpose of the trial: To evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of post-herpes zoster neuralgia.

Test conclusion: This study proved that the experimental drug pregabalin sustained-release tablets had an accurate effect on pain in PHN subjects and worked quickly. The curative effect of long-term medication remained stable, and did not rebound or increase the frequency of explosive pain. Along with pain relief, the test drug also significantly improved the subjects' sleep, and its efficacy characteristics were basically consistent with pain relief. However, short-term improvements in anxiety and depression and emergency dosage were not obvious. Consider factors such as the high proportion of people with mild or moderate anxiety and depression in the overall population of this study, which diluted the efficacy of this part of the overall population. In subgroup analysis, baseline NRS <7 points and baseline NRS ≥7 points were suggested, which were basically consistent with the main findings. The overall safety of the tested drug was good, and the incidence of adverse reactions was similar or lower than that of already marketed products.