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Nanjing Delova's QP-6211 Achieves Major Milestones in Phase 3 Trials

Nanjing Delova Biotech Co., Ltd. has recently made headlines with the announcement of impressive results from two pivotal Phase 3 clinical trials, showcasing the efficacy of QP-6211, an innovative long-acting local anesthetic, for managing postoperative pain. The studies focused on patients who had undergone either hemorrhoidectomy or bunionectomy procedures, demonstrating that QP-6211 effectively met both primary and secondary endpoints compared to placebo and active controls.

Overview of Clinical Trials

The trials were conducted as multicenter, prospective, randomized, double-blind studies, meticulously designed to assess the safety and efficacy of a single-dose QP-6211 delivered through infiltration for postoperative pain relief. The research involved 309 participants for hemorrhoidectomy and 185 participants for bunionectomy, providing robust data on the medication's effectiveness.

Key Findings from Hemorrhoidectomy Study

In the hemorrhoidectomy trial, results indicated that treatment with QP-6211 led to a striking 58% reduction in pain levels as measured by the area under the curve (AUC) of numerical rating scale (NRS) pain intensity scores over the first 72 hours post-surgery. This was a significant improvement over the ropivacaine hydrochloride (ROP HCl) group, which only achieved a 10% reduction. Furthermore, the post-operative opioid consumption among QP-6211 patients decreased by an astounding 88% compared to placebo, while 83% of participants were able to completely avoid opioid use during the same time frame.

Bunionectomy Trial Results

Similar promising trends were observed in the bunionectomy trial, where patients treated with QP-6211 experienced a 49% reduction in pain intensity compared to placebo. The trial also highlighted a significant drop in opioid consumption by 74%, with 75% of patients not requiring opioids in the early recovery phase. These results spotlight QP-6211's potential to redefine postoperative pain management.

Safety Profile of QP-6211

The safety data from both Phase 3 studies revealed that QP-6211 was generally well tolerated, with adverse events primarily categorized as mild to moderate. Importantly, no serious adverse events related to QP-6211 were reported. The incidence of adverse events in both trials was comparable to the placebo groups, reaffirming the product's favorable safety profile.

The Future of QP-6211

Nanjing Delova is optimistic about QP-6211's future, having submitted a New Drug Application (NDA) for approval. The drug employs the company's proprietary Cryslova™ technology, ensuring a sustained release of ropivacaine for at least five days following administration. As a next-generation analgesic, QP-6211 aspires to be a leading, non-opioid option for postoperative pain management, steering towards enhanced patient comfort and reduced reliance on opioid medications, which are often associated with significant side effects and dependency risks.

Nanjing Delova, with its HQ in Nanjing, is dedicated to innovating therapeutic solutions to meet unmet healthcare needs worldwide. The promising results from the Phase 3 trials could indeed signify a major advancement in postoperative care, substantially improving recovery experiences for patients undergoing various surgical procedures.

As the medical landscape continues to evolve, QP-6211 stands out not just as a treatment option but as a potential cornerstone in the future of pain management, changing the way patients approach postoperative recovery.