Nanjing Delova Biotech Co., Ltd. reported positive results from two pivotal Phase 3 clinical trials evaluating QP-6211, a long-acting ropivacaine injection, for the management of postoperative pain following hemorrhoidectomy and bunionectomy surgeries.
The trials demonstrated statistically significant and clinically meaningful reductions in postoperative pain and opioid consumption compared with both ropivacaine hydrochloride injection and placebo.
In both placebo- and active-controlled Phase 3 studies, QP-6211 met the primary endpoint and all key secondary endpoints. Patients treated with QP-6211 experienced superior and sustained pain relief through the critical 72-hour postoperative period, alongside marked reductions in opioid use. A substantial proportion of patients receiving QP-6211 required no opioids during the first 72 hours after surgery.
QP-6211 is an investigational, extended-release formulation of ropivacaine designed to provide prolonged local analgesia following surgical infiltration, with potential applications in peripheral nerve and fascial plane blocks. The formulation uses the company’s proprietary Cryslova™ technology, an aqueous, oil-free injectable suspension that enables continuous and uniform release of ropivacaine for at least five days, with consistent pharmacokinetic performance across surgical models. Ropivacaine is known for its favorable safety profile, including a higher cardiotoxicity threshold and greater selectivity for pain fibers compared with motor fibers.
The hemorrhoidectomy trial enrolled 309 patients in China and showed significant reductions in pain intensity scores and total opioid consumption over 72 hours, as well as higher rates of opioid-free recovery compared with both active control and placebo. Similar outcomes were observed in the bunionectomy trial, which included 185 patients, with QP-6211 demonstrating consistent efficacy across primary and secondary endpoints.
Across both Phase 3 studies, QP-6211 was generally well tolerated. Most adverse events were mild to moderate in severity, and no serious adverse events related to the drug were reported. In the hemorrhoidectomy study, the overall incidence of adverse events was comparable to placebo, while in the bunionectomy study, adverse event rates were lower in the QP-6211 group than in the placebo group.
Based on the positive Phase 3 data, Nanjing Delova has submitted a New Drug Application for QP-6211. The company positions QP-6211 as a next-generation, non-opioid option for postoperative pain management with the potential to reduce reliance on opioid analgesics.
