Heron Therapeutics Announces Initiation of Phase 1b/2 Clinical Study of HTX-034 for the Treatment of Postoperative Pain
05/18/2020
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HTX-034, an investigational non-opioid, is a fixed-dose combination, extended-release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and an additional agent that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as HTX-011. HTX-034 is designed to provide superior and prolonged analgesia and enhance the activity of the local anesthetic bupivacaine via two different mechanisms. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.
The HTX-034 study is a randomized, active-controlled, double-blinded, Phase 1b/2 study in patients undergoing bunionectomy with an osteotomy and internal fixation. The study will evaluate the safety and efficacy of HTX-034 compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The Phase 1b portion of the study is intended to select the optimal dose for the Phase 2 expansion portion.
"We are excited to progress HTX-034 into a proof-of-concept study in patients undergoing bunionectomy, a highly painful surgery, where we have the opportunity to evaluate the magnitude and duration of analgesia," said
About HTX-034 for Postoperative Pain
HTX-034, an investigational non-opioid, is a fixed-dose combination, extended‑release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and an additional agent that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as HTX-011. By combining two different mechanisms that each enhance the activity of the local anesthetic bupivacaine, HTX-034 is designed to provide superior and prolonged analgesia. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.
About HTX-011 for Postoperative Pain
HTX-011, an investigational non-opioid, 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.
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
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