Heron Therapeutics Announces Publication of the Mechanism of Action Data for HTX-011, a Dual-Acting Local Anesthetic Being Developed for Management of Postoperative Pain
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 in a proprietary Biochronomer® polymer. 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 synergistic mechanism of action of HTX-011 was demonstrated in preclinical and clinical studies. Preclinical research in a validated postoperative pig model demonstrated the ability of the low-dose of meloxicam combined with bupivacaine in HTX-011 to address local tissue inflammation at the surgical site, as demonstrated by a less acidic tissue pH level. This maintenance of the physiologic pH level within the surgical site microenvironment was associated with potentiated and prolonged analgesic activity of bupivacaine. The synergy of the low-dose meloxicam combined with bupivacaine in HTX-011 was further confirmed in a Phase 2 bunionectomy study, where HTX-011 achieved superior and sustained pain relief through 72 hours after surgery compared to the Biochronomer polymer formulation of bupivacaine alone, while the Biochronomer polymer formulation of meloxicam alone produced no appreciable pain relief.
"The inability of local anesthetics, including current extended release formulations, to demonstrate consistent postoperative pain relief beyond 24 hours creates challenges for both physicians and patients. This may lead them to use opioids to fill the analgesic gap following surgery," said
The Regional Anesthesia and Pain Medicine article can be found here.
About HTX-011 for Postoperative Pain
HTX-011, an investigational agent, 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. HTX-011 was granted Fast Track designation from the
About Heron Therapeutics, Inc.
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 United States Food and Drug Administration (FDA) approves the New Drug Application (NDA) for HTX-011; the timing of the commercial launch of HTX-011; the timing of the
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