HTX-011, which utilizes our proprietary Biochronomer® drug delivery technology, is under investigation as a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risks of harmful side effects, abuse, and addiction.
HTX-011 is the first long-acting anesthetic that is designed to address both post-operative pain and accompanying inflammation by combining the local anesthetic bupivacaine and the anti-inflammatory meloxicam in a single administration. Targeting both pain and inflammation has allowed HTX-011 to demonstrate an advantage over current standard of care in multiple surgical models-bunionectomy, hernia repair and abdominoplasty (tummy tuck)-in Phase 2 studies.
Across these studies, HTX-011 demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery. These results confirm the broad utility of HTX-011 with successful use across a wide range of surgeries, from small to very large incisions. In addition, data from these studies established, for the first time, the synergy between the local anesthetic bupivacaine and the anti-inflammatory meloxicam in HTX-011, which Heron believes is an important advancement for management of post-operative pain.
Currently, HTX-011 is being evaluated in a broad-based development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain. Following a planned End of Phase 2 meeting with the Food and Drug Administration, Heron anticipates initiating Phase 3 studies in 2017 and filing a New Drug Application in 2018.