Heron Therapeutics’ pain drug HTX-011 has succeeded in two phase 3 trials in patients undergoing bunionectomy and hernia repair by meeting all their primary and key secondary points.
HTX-011, which is a combination of local anesthetic bupivacaine and anti-inflammatory meloxicam, had produced statistically significant reductions in both pain intensity and need for opioids through 72 hours post-surgery.
The primary and key secondary endpoints for the Study 301/EPOCH1 in patients undergoing bunionectomy and Study 302/EPOCH2 phase 3 studies in patients going through hernia repair were identical. HTX-011 was evaluated against placebo and bupivacaine in both the trials.
The primary endpoint was pain intensity, which was assessed by the Area Under the Curve (AUC) score from 0 to 72 hours post-surgery (AUC 0-72), in comparison to placebo.
Key secondary endpoints include comparison of AUC 0-72 of pain intensity to bupivacaine solution and the total amount of opioid rescue medication used compared to placebo during 72 hours after surgery.
Read more: http://clinicaltrials.pharmaceutical-business-review.com/news/herons-pain-drug-succeeds-in-phase-3-bunionectomy-and-hernia-repair-trials-200318-6088474