The initiation of the placebo-controlled, dose-finding trial follows clearance from the US Food and Drug Administration (FDA) of the company’s investigational new drug (IND) application for HTX-011.
HTX-011, which uses the company’s Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.
Around 60 patients undergoing bunionectomy will be included in the trial, which 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 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 chief executive officer Barry Quart said: "We are excited to be moving HTX-011, an innovative product candidate targeting the large and growing post-operative pain management market, into a Phase 2 study in an important surgical indication."
The company intends to report top-line results from this Phase II clinical trial in the second half of this year.