Delova Reports Positive Phase 3 Results for Long-Acting Ropivacaine QP-6211

Delova Reports Positive Phase 3 Results for Long-Acting Ropivacaine QP-6211

By, Admin 6 January 2026

Nanjing Delova has cleared a major clinical hurdle in postoperative pain management. Two pivotal Phase 3 trials show QP-6211 delivered superior pain control and sharply reduced opioid use versus both standard ropivacaine and placebo.

An NDA has now been submitted.

Why QP-6211 Matters?

Postoperative pain remains a key driver of opioid exposure.

QP-6211 is designed to change that.

Key differentiators:

  • Long-acting, extended-release ropivacaine
  • Sustained analgesia through the critical 72-hour postoperative window
  • Consistent efficacy across different surgical models
  • Non-opioid, local infiltration approach

Delova positions QP-6211 as a next-generation, best-in-class local anesthetic.

Phase 3 Trial Overview

Delova conducted two randomized, double-blind, placebo- and active-controlled Phase 3 trials in China.

Surgical models:

  • Hemorrhoidectomy (n=309)
  • Bunionectomy (n=185)

Comparator arms included:

  • Ropivacaine hydrochloride injection
  • Placebo

Hemorrhoidectomy: Strong Pain and Opioid Reduction

QP-6211 met the primary and all key secondary endpoints. Key outcomes versus placebo:

  • 58% reduction in pain (AUC₀–₇₂h NRS)
  • 55% reduction in late pain (AUC₄₈–₇₂h)
  • 88% reduction in opioid consumption
  • 83% of patients required no opioids

All results were statistically significant (p < 0.0001). QP-6211 also outperformed standard ropivacaine across all endpoints.

Bunionectomy: Consistent Efficacy Confirmed

Results closely mirrored the hemorrhoidectomy study.

Key outcomes versus placebo:

  • 49% reduction in pain (AUC₀–₇₂h)
  • 51% reduction in late pain (AUC₄₈–₇₂h)
  • 74% reduction in opioid use
  • 75% of patients avoided opioids entirely

Again, all comparisons were statistically significant.

Safety Profile

QP-6211 was generally well tolerated across both trials.

Key safety observations:

  • Mostly mild to moderate adverse events
  • No treatment-related serious adverse events
  • Overall AE rates comparable to placebo

In the bunionectomy study, AE incidence was lower than placebo.

Technology Behind QP-6211

QP-6211 is built on Delova’s proprietary Cryslova™ platform.

Platform advantages:

  • Oil-free, aqueous injectable suspension
  • Continuous, uniform drug release for at least five days
  • Predictable pharmacokinetics across procedures

Ropivacaine itself offers a higher cardiotoxicity safety margin than bupivacaine, with better sensory selectivity.

What Comes Next?

With two positive Phase 3 trials completed, Delova has:

  • Submitted an NDA for QP-6211
  • Positioned the asset as a non-opioid alternative for postoperative pain
  • Expanded its long-acting analgesic portfolio beyond QAMZOVA®

If approved, QP-6211 could materially reduce opioid exposure after surgery—without sacrificing pain control.

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