Heron Therapeutics Announces Publication of Results from EPOCH 2, a Phase 3 Study of HTX-011 in Patients Undergoing Hernia Repair Surgery
HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. Heron has completed two pivotal Phase 3 studies of HTX-011: EPOCH 1 in bunionectomy, which is a study of a bony tissue surgical model, and EPOCH 2 in hernia repair, which is a study of a soft tissue surgical model.
In EPOCH 2, all primary and key secondary endpoints were achieved. HTX-011 provided superior and sustained pain reduction compared to placebo and bupivacaine solution through the critical 72-hour postoperative window, when pain is often most severe. Significant reductions in pain occurred both early (in the first 8 through 24 hours) and were sustained from 24 through 72 hours. In addition to reductions in average pain intensity scores, HTX-011 significantly reduced the proportion of patients experiencing severe pain through 72 hours compared to placebo and bupivacaine solution. Significant reductions in pain were consistent with the significant decrease in total opioid consumption and the significant increase in opioid-free patients receiving HTX-011, both through 72 hours and as compared to placebo and bupivacaine solution. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.
"Despite the many risks of opioid use, most patients undergoing hernia repair surgery are prescribed opioids after surgery," said Sonia Ramamoorthy, M.D., Chief of Colorectal Surgery at
The Hernia article can be found here.
About EPOCH 2
EPOCH 2 was a randomized, placebo- and active-controlled, double-blind, pivotal Phase 3 clinical study evaluating the efficacy and safety of locally administered HTX-011 at 300 mg/9 mg bupivacaine/meloxicam compared to placebo and the standard dose of bupivacaine solution (75 mg) for postoperative pain control following hernia repair surgery in 418 patients. All primary and key secondary endpoints were achieved:
- There was a 23% reduction in pain intensity as measured by the Area Under the Curve (AUC) 0–72 when comparing HTX-011 to placebo (p<0.001).
- There was a 21% reduction in pain intensity as measured by AUC 0–72 when comparing HTX-011 to the current standard-of-care, bupivacaine solution (p<0.001).
- Over 72 hours post-surgery, patients receiving HTX-011 consumed 38% less opioids than patients receiving placebo (p<0.001) and 25% less opioids than patients receiving bupivacaine solution (p=0.024).
- 51% of patients receiving HTX-011 required no opioid medication for 72 hours post-surgery compared to only 22% receiving placebo (p<0.001) and 40% receiving bupivacaine solution (p=0.049). These results parallel the significantly reduced incidence of severe pain in patients receiving HTX-011 compared to both placebo (40% reduction; p<0.001) and bupivacaine solution (19% reduction; p=0.037).
- Among the HTX-011-treated patients who were opioid-free through 72 hours post-surgery, more than 84% remained opioid-free through day 28.
- HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011; the timing of the EMA Committtee for Medicinal Products for Human Use (CHMP) review process for HTX-011; whether the European Commission authorizes the MAA for HTX-011; and other risks and uncertainties identified in the Company's filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Investor Relations and Media Contact:
Senior VP, General Counsel, Business Development and Corporate Secretary
View original content:http://www.prnewswire.com/news-releases/heron-therapeutics-announces-publication-of-results-from-epoch-2-a-phase-3-study-of-htx-011-in-patients-undergoing-hernia-repair-surgery-300904105.html