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.
In EPOCH1, which was held in 412 patients, HTX-011 at 60mg had shown reduction in pain intensity by 27% as measured by AUC 0-72, in comparison with placebo, and 18% decrease in pain, when compared with bupivacaine solution at 50mg.
During a 72-hour period after surgery, the HTX-011 arm consumed 37% less opioids than the placebo arm and 25% less opioids than the bupivacaine arm.
In the hernia repair trial or the EPOCH2 study held in 418 patients, HTX-011 at 300mg reduced pain by 23% in comparison with placebo and 21% when compared with 75mg of bupivacaine.
The opiods consumption in the HTX-011 arm was 38% lesser than the placebo arm, and 25% lesser than the bupivacaine arm.
Heron Therapeutics CEO Barry Quart said: “With today’s results, HTX-011 is the only locally administered anesthetic to demonstrate superior pain relief and a reduction in opioid use as compared to not only placebo, but also the current standard-of-care, bupivacaine solution, in Phase 3 studies.
“We look forward to submitting a New Drug Application for HTX-011 to the U.S. Food and Drug Administration in the second half of 2018. If approved, we believe that HTX-011 could have a significant impact on the opioid crisis by reducing the use of opioids after surgery, while at the same time allowing patients to experience less pain.”
Image: HTX-011 significantly reduced pain intensity and usage of opiods for 72 hours post surgery in patients who had gone through bunionectomy and hernia repair. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.