Tingting Wang, Yafeng Wang, Haihui Xie, Zhilin Wu, Shuchun Yu, Yangwen Ou, Mingjun Xu, Wanwei Jiang, Liang Ge, Ju Gao, Qiang Wang, Hexin Gao, Yanjuan Huang, Ping Zhao, Yonghao Yu, He Huang, Jinghua Ren, Zhengyuan Xia, Jiaqiang Zhang, Jianbo Yu, Xiangdong Chen
Tegileridine is a biased μ-opioid receptor agonist that selectively activates the G protein pathway, designed to provide analgesia with fewer opioid-related adverse effects. In this phase 3 study, 526 patients with postoperative pain after abdominal surgery were randomized and received placebo, tegileridine at 0.75 mg, tegileridine at 1.0 mg, or morphine. For the primary outcome of effective analgesia, the mean (SD) summed pain intensity difference at rest over the first 24 h from time 0 (SPID 24 ) scores are −61.15 (28.25) and −68.98 (30.33) for the 0.5 and 0.75 mg doses of tegileridine, respectively, compared with −49.63 (29.35) in the placebo group (all p < 0.001) and −71.16 (34.76) in the morphine group. The total pain relief scores (mean [SD]) at 24 h were 58.76 (21.79) with 0.75 mg tegileridine and 61.95 (18.94) with 1.0 mg tegileridine, compared with 47.56 (21.00) with placebo and 59.09 (19.34) with morphine. In summary, tegileridine provides effective analgesia that was significantly superior to placebo and comparable to morphine.