Heron Therapeutics (HRTX +39.8%) jumps out the gate on the heels of its announcement of positive results from two Phase 3 clinical trials assessing long-acting local anesthetic HTX-011 in patients undergoing bunionectomy (Study 301/EPOCH1) and hernia repair (Study 301/EPOCH1).
Both studies met all primary and secondary endpoints demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72 hours post surgery. HTX-011 was well-tolerated with a safety profile comparable to placebo and bupivacaine solution.
The company plans to file a U.S. marketing application in H2.
Fast Track-tagged HTX-011 is an injectable formulation based on the company's Bichronomer polymer-based drug delivery platform which enables the release of bupivacaine and meloxicam over an extended period.
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