Heron Initiates Phase 2 Trial Of HTX-011 For Treatment Of Post-Operative Pain

(RTTNews) - Heron Therapeutics Inc. (HRTX) announced that it has initiated a Phase 2 clinical trial of HTX-011, the Company's lead product candidate for the prevention of post-operative pain, following clearance from the U.S. Food and Drug Administration or FDA of its Investigational New Drug (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 2 clinical trial in approximately 60 patients undergoing bunionectomy will evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo.

In a previously completed, placebo-controlled, Phase 1 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 2-3 days.

Heron said it anticipates reporting top-line results from this Phase 2 clinical trial in the second half of 2015.