Heron Therapeutics has initiated a phase II clinical trial of HTX-011, the company’s lead product candidate for the prevention of post-operative pain, following clearance from the FDA of its IND application for HTX-011. HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.
The placebo-controlled, dose-finding, phase II clinical trial in approximately 60 patients undergoing bunionectomy will evaluate the efficacy and safety of HTX-011, containing 200mg or 400mg of bupivacaine combined with meloxicam, compared to placebo. In a previously completed, placebo-controlled, phase I clinical trial of HTX-011 in healthy volunteers, the desired pharmacokinetic profile for both bupivacaine and meloxicam was achieved, with therapeutically relevant drug levels of bupivacaine sustained for two to three days. Heron anticipates reporting top-line results from this phase II clinical trial in the second half of 2015.