HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials

Area of Science:

• Pharmacology
• Clinical Trials
• Pain Management

Background:

• Postoperative pain following abdominal surgery is a significant clinical challenge.
• Novel analgesics with improved efficacy and safety profiles are needed.
• Kappa opioid receptor agonists offer a potential therapeutic avenue for pain management.

Purpose of the Study:

• To evaluate the efficacy and safety of HSK21542, a peripherally restricted kappa opioid receptor agonist, in patients with postoperative pain after abdominal surgery.
• To compare HSK21542 with placebo and tramadol in two Phase 3 clinical trials.

Main Methods:

• Two multicentre, randomized, double-blind, controlled Phase 3 trials (HSK21542-301 and HSK21542-303) were conducted in China.
• HSK21542 1.0 μg/kg was administered intravenously and compared with placebo (HSK21542-301) or tramadol 50 mg/dose and placebo (HSK21542-303).
• The primary endpoint was the time-weighted summed pain intensity differences over 24 hours (SPID₀₋₂₄ₕ).

Main Results:

• HSK21542 demonstrated statistically significant superiority over placebo in reducing pain intensity in both trials (P < 0.001).
• HSK21542 was non-inferior to tramadol in HSK21542-303 (P < 0.001).
• HSK21542 exhibited a comparable safety profile to placebo, with fewer gastrointestinal adverse events than tramadol.

Conclusions:

• HSK21542 is an effective analgesic for managing postoperative pain following abdominal surgery.
• The drug is well-tolerated and presents a favorable safety profile, comparable to placebo and better than tramadol regarding gastrointestinal adverse events.