China Resources Double-Crane Pharmaceutical (600062.SH) subsidiary Prabalin sustained-release tablets have completed Phase III clinical trials.

China Resources Double-Crane Pharmaceutical (600062.SH) announced that its wholly-owned subsidiary China Resources Double-Crane Pharmaceutical Limin Pharmaceutical (Jinan) Co., Ltd. (referred to as "Double-Crane Limin") has completed the registration and public announcement of Phase III clinical trials for Pregabalin Sustained-release Tablets. Trial Name: A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of Pregabalin Sustained-release Tablets in treating postherpetic neuralgia (PHN). Objective: To evaluate the efficacy and safety of Pregabalin Sustained-release Tablets in treating postherpetic neuralgia. Trial Conclusion: This study demonstrated that the investigational drug, Pregabalin Sustained-release Tablets, has a significant analgesic effect on PHN subjects, with a rapid onset of action. Long-term use maintains stable efficacy without rebound or increased frequency of breakthrough pain. Accompanying the relief of pain, the investigational drug also shows a significant improvement in the sleep quality of subjects, with its efficacy characteristics being consistent with pain relief. However, short-term improvements in anxiety and depression symptoms and the amount of PRN (as needed) medication are less pronounced, likely due to the high proportion of subjects with mild to moderate pain, which diluted the overall treatment effect for this part of the population. Subgroup analysis indicated that results were generally consistent with the main conclusion for baseline NRS scores <7 and 7. The overall safety of the investigational drug is good, with the incidence of adverse reactions being similar to or lower than that of currently marketed products.