Heron Therapeutics NDA for HTX-011

Heron Therapeutics has submitted an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for managing postoperative pain. The therapy was previously granted both Breakthrough Therapy and Fast Track designations.

The submission is based on data from seven clinical studies in bony and soft tissue surgical procedures that included over 1,000 patients who received HTX-011. Data showed that the therapy “demonstrated superior, sustained postoperative pain relief for 72 hours and decreased the need for opioids, with more patients who were opioid-free compared to placebo and bupivacaine solution, the current standard-of-care,” the company says. Its safety profile was found to be similar to bupivacaine solution, without evidence of meloxicam-related toxicities, it adds.