Positive topline results have been reported from the completed phase 3 studies of the investigational agent HTX-011 (Heron Therapeutics) in patients undergoing bunionectomy (Study 301/EPOCH1) and hernia repair (Study 302/EPOCH2). HTX-011 achieved all primary and key secondary endpoints in both phase 3 trials, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72 hours following surgery.
HTX-011 is the first and only long-acting local anesthetic to demonstrate significantly reduced pain and opioid use in phase 3 studies compared with bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control, through 72 hours.
The primary and key secondary endpoints for both studies were identical. The primary endpoint was pain intensity as measured by the area under the curve (AUC) score from 0 to 72 hours after surgery (AUC 0–72) compared with placebo. The key secondary endpoints included the comparison of AUC 0–72 of pain intensity with bupivacaine solution; the total amount of opioid rescue medication consumption compared with placebo through 72 hours after surgery; the proportion of patients who received no opioid rescue medication after surgery compared with bupivacaine solution; and the total opioid consumption through 72 hours after surgery compared with bupivacaine.
HTX-011 was well tolerated in both studies, with a safety profile comparable to placebo and bupivacaine solution. There were no drug-related serious adverse events or discontinuations due to drug-related adverse events in HTX-011-treated patients, and there were fewer opioid-related adverse events in HTX-011-treated patients.
HTX-011 is the first and only long-acting anesthetic designed to address both postoperative pain and inflammation in a single administration at the surgical site. The unique synergy of bupivacaine and meloxicam in HTX-011 has consistently been shown to reduce pain over 72 hours significantly better than bupivacaine alone in multiple diverse surgical models. HTX-011 is administered as a single-dose application via needle-free syringe to directly coat the affected tissue within the surgical site prior to suturing, which makes HTX-011’s route of administration faster, easier, and potentially safer compared to numerous injections required with current local anesthetics.
Source: Heron Therapeutics; March 19, 2018.