HTX-034 is Heron’s next-generation product for the treatment of 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 Heron’s investigational agent 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.
In May 2020, Heron announced the clearance of the U.S. Investigational Drug (IND) application for HTX-034 for the treatment of postoperative pain by the Food and Drug Administration and the initiation of the first in human Phase 1b/2 study of HTX-034 in patients undergoing surgery.