Posted by Michael Wonder on 31 Oct 2018
Heron announces FDA submission of HTX-011 NDA for post-operative pain management
31 October 2018 - Heron Therapeutics today announced the submission of its new drug application to the U.S. FDA for HTX-011.
HTX-011 is an investigational, long-acting, extended-release formulation of the local anaesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of post-operative pain.
HTX-011 was granted both breakthrough therapy and fast track designations from the FDA. The NDA filing is based on the results of 7 completed clinical studies in 5 bony and soft tissue surgical procedures that included over 1,000 patients who received HTX-011. These 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. 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.
