In this study, 77% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) oral acetaminophen and ibuprofen, remained opioid-free through the 72-hour period following surgery and continued to be opioid-free through 28 days of recovery. The mean pain intensity never rose above the mild range through 72 hours postoperatively.
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 (EPOCH 1 in bunionectomy and EPOCH 2 in hernia repair) significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.
'A bunionectomy is a very painful surgical procedure that often requires opioids, which can come with adverse side effects, including nausea, vomiting, constipation and slowed breathing in addition to being potentially addictive,' said
About the EPOCH 1 Follow-On Study
The EPOCH 1 follow-on study was an open-label, multi-cohort study evaluating the efficacy and safety of locally administered HTX-011 60 mg bupivacaine / 1.8 mg meloxicam via needle-free application into the surgical site in combination with a postoperative non-opioid MMA regimen of OTC oral acetaminophen and ibuprofen in 31 patients undergoing unilateral bunionectomy with osteotomy. Key results of the study include the following: 77% of bunionectomy patients receiving HTX-011 with a scheduled non-opioid MMA regimen of OTC acetaminophen and ibuprofen required no opioids during recovery through 28 days (opioid-free).
71% of bunionectomy patients receiving HTX-011 with a scheduled regimen of over-the-counter acetaminophen and ibuprofen did not experience severe pain.
The mean total opioid consumption over the 72-hour postoperative period was 1.61 morphine milligram equivalents.
HTX-011 was well tolerated and demonstrated no safety concerns when used with postoperative non-opioid MMAs (OTC acetaminophen and ibuprofen).
About HTX-011 for Postoperative Pain (ZYNRELEF in the
HTX-011, an investigational non-opioid analgesic, 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. The
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Forward-Looking Statements
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 in the
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