90% of Patients Remain Opioid-Free When HTX-011 Is Given with an Over-the-Counter Analgesic Regimen in New Multi-center Postoperative Pain Management Study
Topline results of the study include the following:
- 90% of patients receiving HTX-011 with the OTC analgesic regimen did not require opioids to manage their postoperative pain through 72 hours post-surgery, compared to 51%, 40% and 22% of patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase 3 study.
- 81% of patients receiving HTX-011 with the OTC analgesic regimen remained opioid-free through 28 days post-surgery.
- Over 72 hours post-surgery, patients receiving HTX-011 plus the OTC analgesic regimen consumed an average of 0.9 morphine milligram equivalents (MME), which compares to 10.8 MME, 14.5 MME and 17.5 MME for patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase 3 study.
"Overprescribing of opioids not only puts patients at risk of persistent use, addiction or dependence, but also results in unused pills available for potential misuse or abuse by others," said
"Reducing discharge prescriptions for opioids after surgery, while providing appropriate pain management, remains a high priority in the battle against the opioid epidemic," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "The results announced today show us that, with HTX-011 as the backbone of a multimodal approach to pain management, patients experience less pain and few need an opioid prescription when they are sent home following outpatient surgery. We look forward to presenting these results in more detail during the upcoming 37th Annual
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 alone in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (
For more information, visit www.herontx.com.
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
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