Heron Therapeutics’ HTX-011 pain drug succeeds in phase 2 clinical study

The company said the drug is better than a placebo in reducing pain in patients undergoing bunionectomy.

The company carried out the randomized, placebo-controlled, double-blind study in 64 patients, who received either 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo.

HTX-011, which uses the company’s Biochronomer drug delivery technology, reduced pain intensity by 69% in 24 hours and by 40% in 72 hours, Heron said.

The drug, which is a combination of local anesthetic bupivacaine and anti-inflammatory meloxicam, was well-tolerated in the study.

Heron said the most frequent adverse events reported include headache, nausea, vomiting, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related.

Heron Therapeutics CEO Barry Quart said: "We are very pleased with these results, and we now will turn our attention to executing on a broad-based development program designed to enable us to bring HTX-011 to the many patients undergoing a wide range of surgeries who experience significant post-operative pain."

In a Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam. Therapeutically relevant plasma bupivacaine levels were sustained for two to three days.

The anesthetic effects of HTX-011 persisted for about three days, which closely correlated with plasma bupivacaine concentrations, and the drug was well-tolerated with no serious adverse incidents.