TQ-1011 is superior to morphine and placebo in alleviating moderate to severe postsurgical pain

Abstract

TQ-1011 is an injectable non-opioid analgesic under clinical investigation for the treatment of acute postsurgical pain. This single dose, single-center, double blind, randomized study compared the analgesic efficacy and safety of intravenous (IV) doses of TQ-1011, 50 and 100 mg, with morphine sulfate 4 mg and placebo in patients with moderate to severe postsurgical pain following third molar surgery. Each treatment was administered over 2 minutes. One hundred and thirty patients (44 M, 86 F) with moderate or severe post-surgical pain were assessed. Pain intensity (using standard categorical and visual analog scales) and pain relief (categorical only) were assessed at baseline and 12 time points over 8 hours following dosing. Times to perceptible and meaningful pain relief were measured by stopwatch and were used to determine time to onset of analgesia. The a priori primary measure of efficacy was Total Pain Relief (TOTPAR) 0–4. Secondary measures of efficacy included TOTPAR (at other time points), Sum of Pain Intensity Difference (SPID), Sum of Pain Relief Intensity Difference (SPRID), Time to First Rescue, Peak Pain Intensity Difference (PPID), Peak Pain Relief (PPR), Time to Confirmed Perceptible Pain Relief (onset) and Patient Global Evaluation. Safety was assessed during the study and at follow-up 5–10 days post-treatment by chemistry, hematology, urinalysis, vital signs and volunteered or observed adverse effects. All efficacy analyses were performed on the Intent-to-Treat population. TQ-1011 50 mg and 100 mg were well tolerated. Both doses provided rapid onset of effect (5 and 7 minutes) and significant analgesic efficacy. The TOTPAR 0–4 for TQ-1011 50 mg, 100 mg, morphine 4 mg and placebo were 10.6, 11.6, 2.7 and 2.8, respectively. On every measure of efficacy, TQ-1011 50 mg and 100 mg IV were superior to IV morphine 4 mg and placebo (p<0.001). This research was sponsored by TheraQuest Biosciences.