Research & Development
Heron files HTX-011's NDA with US FDA for postoperative pain management
1 November 2018 -

Biotechnology company Heron Therapeutics Inc (Nasdaq:HRTX) said on Wednesday that it has filed its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for HTX-011 for the management of postoperative pain.

Utilising the company's proprietary Biochronomer drug delivery technology, the HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX-011 was granted both Breakthrough Therapy and Fast Track designations from the US FDA.

This US NDA filing is based on the results from the company's seven completed clinical studies in five bony and soft tissue surgical procedures that included over 1,000 patients who received HTX-011.

The completed clinical studies included two Phase 3 studies in which HTX-011 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, added the company.

According to the company, the overall safety profile of HTX-011, administered locally into the surgical site without a needle, is similar to that of the well-established safety profile of bupivacaine solution, without evidence of meloxicam-related toxicities.

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